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    v1.0.28
    OpenPayerPolicy UpdatesLaboratory/PathologyWellCare FerriScan R2‑MRI Coverage & Prior Auth | …
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    CurrentWellCarePolicy CP.MP.53

    FerriScan R2-MRI

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    Defines medical necessity criteria for use of the FerriScan R2-MRI test to quantify liver iron concentration (LIC) in members suspected of iron overload; applies to providers submitting coverage requests to WellCare health plans.

    Policy Summary
    PayerWellCare
    PolicyFerriScan R2-MRI
    Policy CodePolicy CP.MP.53
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization and submit appropriate CPT coding (policy references unlisted MR code 76498) when requesting FerriScan R2-MRI for suspected iron overload.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    I. Criteria listDistinct indication groups listed as medically necessary
    510(k) K043271FDA clearance for R2-MRI Analysis System
    1.5T & 3TScanner compatibility stated
    76498Coding example included

    Coverage Criteria

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Medically Necessary Indications

    Covered when ANY of the following suspected causes of iron overload are present:

    Indications: A. Hereditary hemochromatosis; B. Iron-loading anemias with or without multiple transfusions: 1. Thalassemia major or thalassemia intermedia; 2. Sideroblastic anemia; 3. Chronic hemolytic anemias (e.g., sickle cell disease); 4. Inherited or acquired aplastic anemia; 5. Myelodysplastic syndromes; 6. Hematopoietic stem cell transplantation; C. Dietary iron overload; D. Iron overload in liver diseases: 1. Hepatitis C or B; 2. Alcohol-induced liver disease; 3. Porphyria cutanea tarda; 4. Fatty liver disease; 5. Gestational alloimmune liver disease; 6. Suspicion of rare genetic variants affecting iron absorption or distribution; E. Neonatal iron overload; F. Aceruloplasminemia; G. Repeated hemin infusions for acute porphyrias; H. Hemodialysis for end stage renal failure.

    List taken verbatim from policy section I.

    The policy specifies that R2‑MRI quantifies liver iron by measuring the transverse relaxation rate (R2) from MR signal decay and converting those data to liver iron concentration. However, the document explicitly states that R2‑MRI will not detect cellular liver damage due to iron overload and therefore does not replace assessment of cellular injury.

    Covered Indications

    Measurement of Liver Iron Concentration — Covered Indications

    Measurement of liver iron concentration is covered when suspected iron overload is due to any of the following conditions:

    Covered indications: Hereditary hemochromatosis; Iron-loading anemias (with or without multiple transfusions) including: thalassemia major or intermedia; sideroblastic anemia; chronic hemolytic anemias (e.g., sickle cell disease); inherited or acquired aplastic anemia; myelodysplastic syndromes; hematopoietic stem cell transplantation; Dietary iron overload; Iron overload in liver diseases including: hepatitis C or B; alcohol-induced liver disease; porphyria cutanea tarda; fatty liver disease; gestational alloimmune liver disease; suspicion of rare genetic variants affecting iron absorption or distribution; Neonatal iron overload; Aceruloplasminemia; Repeated hemin infusions for acute porphyrias; Hemodialysis for end stage renal failure.

    Taken from policy section I.

    Coding and Test Information

    Referenced CPT CodesCPT
    76498Unlisted magnetic resonance procedure (eg, diagnostic, interventional)
    LIC correlation to biopsy
    Role of mean LICMean LIC provided in the FerriScan report is used to guide chelation therapy
    Correlation with biopsyMeasurements shown to have high sensitivity and specificity for LIC measured by biopsy
    Effect of fibrosis/cirrhosisResults are unaffected by the presence of fibrosis or cirrhosis

    Provider Actions & Billing Notes

    Prior Authorization

    Prior authorization required for FerriScan R2‑MRI; use appropriate CPT coding

    FerriScan R2‑MRI requires prior authorization and is considered medically necessary only when used to measure liver iron concentration for the specified iron‑overload indications listed in the policy; when submitting authorization requests, providers should use appropriate CPT coding (policy references unlisted MR code 76498) and follow the plan prior authorization processes.

    • Medically necessary indications include hereditary hemochromatosis; iron‑loading anemias (eg, thalassemia, sideroblastic anemia, chronic hemolytic anemias, aplastic anemia, myelodysplastic syndromes, post‑transplant); dietary iron overload; iron overload in liver diseases (eg, hepatitis B/C, alcohol‑related disease, fatty liver, porphyria cutanea tarda, gestational alloimmune liver disease, suspected rare genetic variants); neonatal iron overload; aceruloplasminemia; repeated hemin infusions; and hemodialysis.
    • Use CPT guidance when selecting procedure codes; this policy references CPT 76498 (Unlisted magnetic resonance procedure) as an example.
    Note

    Follow plan prior authorization and documentation processes

    Providers must follow plan prior authorization and documentation processes for FerriScan R2‑MRI and ensure requests align with the medically necessary indications enumerated in the policy.

    • Ensure the clinical indication submitted matches one of the policy’s listed causes of suspected iron overload.
    • Adhere to the Health Plan’s administrative prior authorization procedures and any plan‑level requirements.
    Billing Rule

    Coding and documentation note — verify current CPT guidance

    When submitting claims for FerriScan R2‑MRI, providers should reference current CPT guidance; inclusion or exclusion of codes in this policy does not guarantee coverage and coverage remains subject to plan contract terms.

    • Codes shown in the policy are informational only; verify the most up‑to‑date professional coding guidance prior to claim submission.
    • The policy references CPT 76498 (Unlisted magnetic resonance procedure) as an example, but that does not ensure reimbursement.
    Denial Risk

    Coverage subject to plan terms and contract requirements

    Coverage and administration of benefits for FerriScan R2‑MRI are governed by the member’s plan documents and applicable state/federal requirements; claims may be denied if services do not meet plan contract terms.

    • This policy is a guide to medical necessity and does not guarantee payment or results.
    • Providers should confirm eligibility, benefits, and any contract exclusions or limitations before ordering the test.

    Ordering Requirements

    Step Therapy

    Ordering requirements and plan processes

    Providers must follow plan‑level prior authorization and documentation processes when ordering FerriScan R2‑MRI; there are no specialty‑specific ordering restrictions specified in the policy.

    • Submit prior authorization and supporting documentation according to the member’s Health Plan procedures.
    • Confirm the indication aligns with the policy’s listed medically necessary conditions for iron overload.

    Not Covered

    Use of R2‑MRI to detect cellular liver injury is not covered. The policy makes no additional explicit exclusions beyond this limitation to the diagnostic capability of R2‑MRI; it is intended for noninvasive quantification of liver iron concentration and not for evaluation of cellular-level hepatic damage.

    Definitions

    R2 (Transverse relaxation rate)
    Definition (R2)Transverse relaxation rate (R2) determined by fitting signal decay curves across echo times to quantify liver iron on a voxel-by-voxel basis
    MethodR2 images are produced by fitting signal decay curves to image signal intensities at different echo times
    CalibrationR2 images may be transformed by a defined calibration to provide quantitative liver iron concentration values
    FerriScan R2-MRI
    What FerriScan R2-MRI isAn MRI-based analysis system that creates liver iron concentration (LIC) maps from image data acquired on MRI scanners and calculates mean LIC
    WorkflowImage data are electronically transmitted to a central data analysis center where acquisition is verified and LIC results are returned to the originating MRI center
    Scanner compatibilityCan be set up on most 1.5 Tesla scanners and is available for 3 Tesla scanners
    Regulatory statusR2-MRI Analysis System received FDA 510(k) clearance (K043271); FerriScan authorized as an imaging companion diagnostic for Exjade (per policy)

    Frequency Limits

    Frequency limits
    Policy statementFrequency limits not specified in this policy
    Implication for orderingProviders should follow plan-level prior authorization and documentation processes for test timing
    Frequency field in briefLaboratory frequency_limits entry: Not specified in policy
    Policy Summary
    PayerWellCare
    PolicyFerriScan R2-MRI
    Policy CodePolicy CP.MP.53
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization and submit appropriate CPT coding (policy references unlisted MR code 76498) when requesting FerriScan R2-MRI for suspected iron overload.
    SourceLink
    On This Page
    Coverage CriteriaCovered IndicationsCoding and Test InformationProvider Actions & Billing NotesOrdering RequirementsNot CoveredBackgroundDefinitionsFrequency Limits