CurrentCentenePolicy N/A

FerriScan R2-MRI for liver iron concentration

Coverage policy governing use of the FerriScan R2-MRI test to measure liver iron concentration (LIC) in members with suspected iron overload conditions. Affects providers requesting FerriScan R2-MRI for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyFerriScan R2-MRI for liver iron concentration

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionBill FerriScan R2-MRI using CPT 76498 and follow plan-specific prior authorization and coding guidance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1unlisted CPT code referenced (76498)

I.A–HMedically necessary indication categories

K043271FDA clearance referenced

3T3T availability noted

Coverage Criteria for FerriScan R2-MRI

Medically Necessary Indications

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Indications for medically necessary FerriScan R2-MRI: 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.

Policy lists these as medically necessary indications.

The policy notes a modality limitation: R2‑MRI will not detect cellular liver damage due to iron overload. While R2‑MRI quantifies liver iron concentration by fitting signal decay curves to derive R2 images and calibrated LIC values, it does not assess cellular injury from iron deposition and should not be used for that purpose.

Appropriate Uses — Covered Indications

Appropriate use for noninvasive quantification of liver iron concentration in listed iron overload conditions

Appropriate use: FerriScan R2-MRI is appropriate for noninvasive quantification of liver iron concentration (LIC) for patients with the listed iron overload conditions.

Image data are acquired on an MRI scanner and electronically transmitted to a data analysis center for centralized analysis (see coding/operations).

Provider Actions, Billing, and Documentation

Prior Authorization

Prior Authorization — Verify per plan

Prior authorization requirements may vary by Centene plan. Providers should verify plan-specific prior authorization rules before scheduling FerriScan R2‑MRI. When submitting for prior authorization, include clinical documentation that the request meets the medically necessary indications listed in the policy (I.A–I.H).

Prior authorization may be required per member plan rules; confirm with the member's specific Centene plan.
Include documentation demonstrating the patient meets one of the medically necessary indications (I.A–I.H).
If prior authorization is required, attach relevant clinical notes, labs, transfusion history, and prior imaging as applicable.

Billing Rule

Billing / Coding Guidance

Use CPT code 76498 (Unlisted magnetic resonance procedure) for billing FerriScan R2‑MRI and follow the payer's coding guidance for unlisted procedure reporting. Providers must submit supporting documentation (procedure description, R2 analysis report, and rationale) with claims to justify the unlisted CPT code.

Bill FerriScan R2‑MRI as CPT 76498 (Unlisted magnetic resonance procedure).
Attach the FerriScan R2 analysis report and a clear procedure description when submitting claims.
Consult the plan's coding guidance for any additional billing requirements or modifier use.

Denial Risk

Denial Risk for Lack of Indication

Requests that do not meet the policy's specified medically necessary indications (I.A–I.H) are at risk for denial. Absence of adequate clinical justification, insufficient documentation of iron‑overload risk, or lack of relevant laboratory/imaging data may result in claim denial or denial of prior authorization.

Denials may occur if the patient does not meet one of the listed indications for FerriScan R2‑MRI (I.A–I.H).
Provide transfusion history, relevant diagnoses (e.g., thalassemia, hemochromatosis), and supporting labs to reduce denial risk.
If denied for lack of indication, appeals should include additional clinical evidence tying the request to an indicated condition.

Step Therapy

No step therapy requirements apply to FerriScan R2‑MRI under this policy.

There are no step therapy or prior‑treatment sequencing requirements specified for this service.

Not Covered / Limitations

Use of R2‑MRI to detect cellular liver damage is not supported by this policy. The R2‑MRI Analysis System provides validated measurement of liver iron concentration but will not detect cellular liver damage due to iron overload and therefore is not an appropriate test for identifying cellular injury.

Definitions

FerriScan R2-MRI (R2-MRI Analysis System)

DefinitionFerriScan R2-MRI is an MRI-based analysis system that fits signal decay curves across echo times on a voxel-by-voxel basis to determine transverse relaxation rate (R2) images and, after defined calibration, provides quantitative measures of liver iron concentration (LIC)

Operational principleFits signal decay curves to image signal intensities at different echo times to produce R2 images which are calibrated to quantify LIC

Regulatory statusR2-MRI Analysis System (Inner Vision Biometrics PTY LTD) received FDA 510(k) clearance K043271 (cleared Jan 21, 2005)

Background

Iron overload can lead to damage of multiple organs including the liver, heart, and endocrine organs. Treatment options for clinically significant iron overload commonly include phlebotomy, iron chelation therapy, or exchange transfusion, depending on the underlying disorder and severity. FerriScan R2‑MRI is used to noninvasively quantify liver iron concentration to inform management in the listed iron‑overloading conditions.

Revision History

10/23Annual Review / RevisionLatest

Annual review with addition of criterion I.B.6 (Hematopoietic stem cell transplantation) and I.D.6 (suspicion of rare genetic variants); background and references updated; CPT code description reviewed.

10/22Annual Review

Annual review; background updated with no impact on criteria; references reviewed and updated.

10/21Annual Review

Annual review; added 'Hemodialysis for end stage renal failure' as an indication; references reviewed and updated; background updated with no clinical significance.

10/19Revision / Approval

References reviewed and updated; replaced codes D61.89 and D61.9 with expanded range D61.01–D61.9; terminology updated replacing 'member' with 'member/enrollee'.

11/12Policy Development / Approval

Policy developed and approved; references reviewed and updated; specialist review documented.