CurrentUnitedHealthcarePolicy 2026D0088Q

Intravenous Iron Replacement Therapy (Feraheme, Injectafer, & Monoferric)

UnitedHealthcare medical benefit drug policy governing coverage criteria, initial and continuation authorization requirements, and applicable coding for IV iron products Feraheme (ferumoxytol), Injectafer (ferric carboxymaltose), and Monoferric (ferric derisomaltose). Excludes certain IV iron products from these criteria and references Medicare/CMS guidance.

Policy Summary

PayerUnitedHealthcare

PolicyIntravenous Iron Replacement Therapy (Feraheme, Injectafer, & Monoferric)

Policy CodePolicy 2026D0088Q

Change TypeDefinitions and supporting information updated; prior version archived

Effective DateFeb 1, 2026

Next Review Date

Key ActionProvider must submit medical records (labs, chart notes) supporting IDA diagnosis and, when required, lab evidence of prior IV therapy failure obtained within 4 to 12 weeks after last dose.

SourceLink

POLICY UPDATE CHANGES

Updated definition of 'Iron Deficiency Anemia (IDA) With CKD, Without End Stage Renal Disease (ESRD), or Acute or Chronic Inflammatory Conditions' and updated supporting information, clinical evidence, CMS, and references.

3IV iron products covered by criteria

3Preferred IV iron alternatives referenced

12Month max authorization

4-12 weeksLab timing window for treatment-failure documentation

Coverage Summary

Scope: This UnitedHealthcare medical benefit drug policy (Policy Number 2026D0088Q, effective February 1, 2026, last reviewed February 1, 2026) governs coverage criteria, initial and continuation authorization requirements, and applicable coding for intravenous iron products Feraheme (ferumoxytol), Injectafer (ferric carboxymaltose), and Monoferric (ferric derisomaltose).

Covered and excluded products: The policy applies to Feraheme, Injectafer, and Monoferric. The policy does not apply to Ferrlecit, Infed, and Venofer for the coverage criteria in the main section.

Coverage stance and applicability: Overall coverage stance is mixed — specific medical necessity criteria and prior authorization requirements apply (including documentation, lab timing windows, and prescriber attestation). The policy references Medicare/CMS guidance and specifically notes Medicare National Coverage Determination NCD 110.10 for Intravenous Iron Therapy where applicable to Medicare reviews.

Policy thresholds and stats

Serum ferritin (IDA without CKD)< 30 ng/mL

Transferrin saturation (TSAT)< 20%

Serum ferritin (IDA with CKD)< 100 ng/mL; if 100-300 ng/mL then TSAT < 20% required

Injectafer heart failure ferritin thresholdSerum ferritin < 100 ng/mL OR ferritin 100-300 ng/mL with TSAT < 20%

Injectafer heart failure LVEF< 45%

Injectafer heart failure Hb< 15 g/dL

Pediatric ferritin (age <12)≤ 15 µg/L

Month max authorization12 months

Lab timing window for treatment-failure documentation4-12 weeks after last IV iron dose

Initial Therapy Criteria

Iron Deficiency Anemia (IDA) Without Chronic Kidney Disease (CKD) — Feraheme and Injectafer

Feraheme and Injectafer are medically necessary when ALL initial therapy criteria are met for IDA without CKD:

ALL of the following

Required documentation: Submission of medical records (e.g., lab values, chart notes) supporting diagnosis of IDA
CKD exclusion: Patient does not have CKD
ONE of
- Oral iron failure/intolerance: History of failure, contraindication, or intolerance to oral iron therapy

General Scope and Product Applicability

General Scope / Products

Policy applies to the following intravenous iron replacements and excludes others:

Products in scope and exclusions

Applies to Feraheme (ferumoxytol), Injectafer (ferric carboxymaltose), and Monoferric (ferric derisomaltose)
Does not apply to Ferrlecit (sodium ferric gluconate complex), Infed (iron dextran), and Venofer (iron sucrose)
Monoferric medical necessity note: Monoferric is not medically necessary for the treatment of any diagnosis addressed within this policy; published evidence does not demonstrate superiority

Continuation Therapy Criteria

Continuation of therapy (IDA without CKD)

Continuation of therapy (IDA without CKD) — required documentation, lab timing, dosing conformity, and 12-month authorization limit:

Continuation (IDA without CKD) - requirements

Prior coverage requirement: Coverage previously provided by UnitedHealthcare for Feraheme or Injectafer for IDA based on documented history of intolerance/contraindication/severe adverse event to all three preferred IV products OR treatment failure of at least two preferred IV products
Recent laboratory results: Submission of recent laboratory results within the past 4 to 12 weeks since the last Feraheme or Injectafer administration to demonstrate need for additional therapy4-12 weeks
CKD exclusion:

Definitions & Diagnostic Thresholds

Definitions — Iron Deficiency Anemia (IDA) Without CKD: For adults and pediatric patients ≥ 12 years, IDA is defined as serum ferritin < 30 ng/mL or transferrin saturation (TSAT) < 20% or absence of stainable iron in bone marrow. For pediatric patients < 12 years, IDA is hemoglobin below age/gender cutoffs plus one of: serum ferritin ≤ 15 µg/L or reticulocyte hemoglobin content (CHr) / RET‑He supportive.

Definitions — IDA With CKD (without ESRD): IDA is defined as serum ferritin < 100 ng/mL or TSAT < 20%; if serum ferritin is 100–300 ng/mL then TSAT < 20% is required to confirm iron deficiency.

Diagnostic thresholds used in this policy (explanatory): For IDA without CKD the policy uses serum ferritin < 30 ng/mL or TSAT < 20% (or bone marrow iron absence) as primary diagnostic cutoffs in adults and those ≥ 12 years. Pediatric thresholds differ by age with ferritin ≤ 15 µg/L or CHr/RET‑He used to support the diagnosis in children < 12 years. For IDA associated with CKD (without ESRD) the policy adopts a higher ferritin threshold (< 100 ng/mL) and requires TSAT < 20% when ferritin is between 100 and 300 ng/mL.

Policy thresholds

Serum ferritin (IDA without CKD)< 30 ng/mL

Transferrin saturation (TSAT)< 20%

Provider Actions & Requirements

Prior Authorization

Prior authorization required for initial and continuation therapy

Initial and continuation authorizations for Feraheme or Injectafer require prior authorization. Authorizations are limited to no longer than 12 months and require documentation of prior therapy failure/intolerance or prescriber attestation as specified in the policy.

Documentation Required

Submit supporting medical records and labs

Submit medical records (e.g., lab values, chart notes) supporting the diagnosis of iron deficiency anemia. When relying on prior IV therapy failure, include laboratory values demonstrating treatment failure obtained within 4 to 12 weeks following the last IV iron dose. Examples of required documents include serum ferritin, transferrin saturation (TSAT), hemoglobin, and relevant chart notes documenting prior therapies and responses.

Lab timing window: laboratory values should be obtained within 4 to 12 weeks following the last dose of intravenous iron.

Applicable Codes

J-codes (drug HCPCS)HCPCS

J1437	Injection, ferric derisomaltose, 10 mg
J1439	Injection, ferric carboxymaltose, 1 mg
Q0138	Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non-ESRD use)
Q0139	Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (for ESRD on dialysis)

ICD-10 Diagnosis Codes (referenced)ICD-10

D50.0	Iron deficiency anemia secondary to blood loss (chronic)
D50.1	Sideropenic dysphagia
D50.8	Other iron deficiency anemias
D50.9	Iron deficiency anemia, unspecified
D63.1	Anemia in chronic kidney disease
I12.9	Hypertensive chronic kidney disease with stage 1 through stage 4 CKD, or unspecified CKD
I13.0	Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 CKD, or unspecified CKD
I13.10	Hypertensive heart and chronic kidney disease without heart failure, with stage 1 through stage 4 CKD, or unspecified CKD
I50.1	Left ventricular failure, unspecified
I50.20	Unspecified systolic (congestive) heart failure

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Clinical Evidence & Guidance

Evidence summary: The policy cites product-specific FDA labeling for Feraheme, Injectafer, and Monoferric as sources of indication information.

Clinical guideline evidence: The policy references multiple professional society guidelines and guidance (including KDIGO, AGA, ESC, and AHA/ACC/HFSA) supporting the use of intravenous iron in patients who are intolerant of or do not respond to oral iron and in CKD and heart failure populations.

Clinical interpretation: Guideline and systematic review evidence noted in the policy supports IV iron when oral iron is ineffective or not tolerated and supports IV iron in selected CKD and heart failure contexts to improve iron indices, exercise capacity, symptoms, and other outcomes as reflected in the referenced guideline statements and trials.

Background

Background: IV iron therapy is used for iron deficiency anemia resulting from decreased intake, reduced absorption, or blood loss. Parenteral iron provides supplemental iron that increases iron stores and can raise hemoglobin and hematocrit, and in some settings reduce erythropoiesis‑stimulating agent requirements.

Regulatory and guideline context: The policy references FDA product indications for Feraheme, Injectafer, and Monoferric and numerous professional society guidelines (KDIGO, AGA, ESC, AHA/ACC/HFSA) that support IV iron use when oral iron is ineffective or not tolerated and in CKD and heart failure settings.

Policy scope and payer applicability: This document is a UnitedHealthcare Medical Benefit Drug Policy intended to guide interpretation of standard benefit plans for IV iron products (medical benefit drugs). It notes that member‑specific benefit documents and applicable federal or state mandates govern coverage decisions and that Medicare coverage should reference NCD 110.10 where applicable.

Revision History

2026-02-01revisedLatest

Revised: Archived previous policy version 2025D0088P; updated definition of 'Iron Deficiency Anemia (IDA) With CKD, Without End Stage Renal Disease (ESRD), or Acute or Chronic Inflammatory Conditions' and updated supporting information, clinical evidence, CMS, and references.

Policy Summary

PayerUnitedHealthcare

PolicyIntravenous Iron Replacement Therapy (Feraheme, Injectafer, & Monoferric)

Policy CodePolicy 2026D0088Q

Change TypeDefinitions and supporting information updated; prior version archived

Effective DateFeb 1, 2026

Next Review Date

Key ActionProvider must submit medical records (labs, chart notes) supporting IDA diagnosis and, when required, lab evidence of prior IV therapy failure obtained within 4 to 12 weeks after last dose.

SourceLink

On This Page

Preferred IV failure or intolerance pathways

Treatment failure to preferred IVs: Submission of laboratory values demonstrating treatment failure to at least two of: Ferrlecit (sodium ferric gluconate), Infed (iron dextran), Venofer (iron sucrose). Laboratory values should be obtained within 4 to 12 weeks following the last IV iron dose; prescriber attests that response with Feraheme or Injectafer would be expected to be superior
Intolerance/contraindication to preferred IVs: History of intolerance, contraindication, or severe adverse event to all of: Ferrlecit, Infed, Venofer; prescriber attests the same event would not be expected with Feraheme or Injectafer

Dosing and authorization: Feraheme or Injectafer dosing must be in accordance with FDA approved labeling; initial authorization will be for no longer than 12 months

Continuation of therapy (IDA without CKD)

Prior coverage requirement: Coverage previously provided by UnitedHealthcare for Feraheme or Injectafer for IDA based on documented history of intolerance/contraindication/severe adverse event to all three preferred IV products OR treatment failure of at least two preferred IV products
Recent labs: Submission of recent laboratory results within the past 4 to 12 weeks since the last Feraheme or Injectafer administration to demonstrate need for additional therapy4-12 weeks
CKD exclusion for continuation: Patient does not have CKD
Dosing conformity and authorization period: Feraheme or Injectafer dosing must be consistent with FDA labeling; continuation authorization will be for no longer than 12 months12 months

Preferred IV iron therapy failure/intolerance conditions (referenced above)

Failure documentation: Submission of laboratory values demonstrating treatment failure to at least two of: Ferrlecit, Infed, Venofer; lab timing 4-12 weeks; prescriber attests expected superior response with Feraheme/Injectafer4-12 weeks
Intolerance pathway: History of intolerance/contraindication/severe adverse event to all preferred IVs; prescriber attests the same would not be expected with Feraheme/Injectafer

Iron Deficiency Anemia (IDA) Associated with CKD without ESRD — Feraheme and Injectafer

Feraheme and Injectafer are medically necessary when ALL initial therapy criteria are met for IDA associated with CKD (without ESRD):

Top-level initial criteria for IDA with CKD (no ESRD)

Diagnosis and documentation: Diagnosis of IDA and CKD with submission of medical records (e.g., lab values, chart notes) supporting diagnosis
ESRD exclusion: Patient does not have ESRD
CKD-dependent pathways
- Dialysis-dependent CKD: Patient's CKD requires hemodialysis or peritoneal dialysis treatment
- Non-dialysis CKD with oral iron failure: Patient's CKD does not require hemodialysis or peritoneal dialysis treatment AND history of failure, contraindication, or intolerance to oral iron therapy
ONE of (examples and preferred IV failure/intolerance)
- Clinical examples: Patient has severe iron deficiency in late-stage pregnancy OR impaired absorption due to prior gastric surgery or GI disorder OR blood loss exceeding oral repletion capability
- Treatment failure to preferred IVs: Submission of laboratory values demonstrating treatment failure to at least two of: Ferrlecit, Infed, Venofer. Laboratory values should be obtained within 4 to 12 weeks following the last IV iron dose; prescriber attests expected superior response with Feraheme/Injectafer4-12 weeks
- Intolerance to preferred IVs: History of intolerance, contraindication, or severe adverse event to all preferred IV therapies; prescriber attests the same would not be expected with Feraheme/Injectafer
Dosing and authorization: Feraheme or Injectafer dosing in accordance with FDA labeling; initial authorization will be for no longer than 12 months12 months

Continuation of therapy (IDA with CKD without ESRD)

Prior coverage requirement: Coverage previously provided by UnitedHealthcare for Feraheme or Injectafer for IDA with CKD based on documented history of intolerance/contraindication/severe adverse event to all three preferred IV products OR treatment failure of at least two preferred IV products
ESRD exclusion for continuation: Patient does not have ESRD
Recent labs: Submission of recent laboratory results within the past 4 to 12 weeks since the last Feraheme or Injectafer administration to demonstrate need for additional therapy4-12 weeks
Dosing conformity and authorization period: Feraheme or Injectafer dosing must be in accordance with FDA labeling; continuation authorization will be for no longer than 12 months

Injectafer for Iron Deficiency in Heart Failure (NYHA II/III)

Injectafer is medically necessary to improve exercise capacity in adult patients with heart failure when ALL initial therapy criteria are met:

Top-level initial criteria for Injectafer in heart failure

Laboratory evidence (ONE of)
- Ferritin low: Serum ferritin < 100 ng/mL< 100 ng/mL
- Ferritin 100-300 with low TSAT: Serum ferritin 100 to 300 ng/mL AND transferrin saturation (TSAT) < 20%ferritin 100-300 ng/mL; TSAT < 20%
NYHA class
- NYHA II: NYHA class II heart failure
- NYHA III: NYHA class III heart failure
LVEF: Left ventricular ejection fraction (LVEF) < 45%< 45%
Hemoglobin (Hb) < 15 g/dL< 15 g/dL
Preferred IV failure/intolerance
- Treatment failure to preferred IVs: Submission of laboratory values demonstrating treatment failure to at least two of: Ferrlecit, Infed, Venofer; lab values obtained within 4 to 12 weeks following last IV dose; prescriber attests expected superior response with Injectafer4-12 weeks
- Intolerance to preferred IVs: History of intolerance, contraindication, or severe adverse event to all preferred IV therapies; prescriber attests the same event would not be expected with Injectafer
Dosing and authorization: Injectafer dosing in accordance with FDA labeling for iron deficiency in heart failure; initial authorization will be for no longer than 12 months12 months

Continuation of therapy (Injectafer for heart failure)

Prior coverage requirement: Coverage previously provided by UnitedHealthcare for Injectafer based on documented history of intolerance/contraindication/severe adverse event to all three preferred IV products OR treatment failure of at least two preferred IV products
Recent labs for continuation: Submission of recent laboratory results within the past 4 to 12 weeks since the last Injectafer administration to demonstrate need for additional therapy4-12 weeks
Dosing conformity and authorization period: Injectafer dosing must be in accordance with FDA labeling for heart failure; continuation authorization will be for no longer than 12 months12 months

Patient does not have CKD

Dosing conformity: Feraheme or Injectafer dosing must be in accordance with FDA approved labeling

Authorization limit: Continuation authorization will be for no longer than 12 months12 months

Continuation of therapy (IDA with CKD without ESRD)

Continuation of therapy (IDA with CKD without ESRD) — required documentation, exclusion of ESRD, lab timing, dosing conformity, and 12-month authorization limit:

Continuation (IDA with CKD without ESRD) - requirements

Prior coverage requirement: Coverage previously provided by UnitedHealthcare for Feraheme or Injectafer for IDA with CKD based on documented history of intolerance/contraindication/severe adverse event to all three preferred IV products OR treatment failure of at least two preferred IV products
ESRD exclusion: Patient does not have ESRD
Recent laboratory results: Submission of recent laboratory results within the past 4 to 12 weeks since the last Feraheme or Injectafer administration to demonstrate need for additional therapy4-12 weeks
Dosing conformity: Feraheme or Injectafer dosing must be in accordance with FDA approved labeling
Authorization limit: Continuation authorization will be for no longer than 12 months12 months

Continuation of therapy (Injectafer for heart failure)

Continuation of therapy (Injectafer for heart failure) — required documentation, lab timing, dosing conformity, and 12-month authorization limit:

Continuation (Injectafer for heart failure) - requirements

Prior coverage requirement: Coverage previously provided by UnitedHealthcare for Injectafer for treatment of iron deficiency based on documented history of intolerance/contraindication/severe adverse event to all three preferred IV products OR treatment failure of at least two preferred IV products
Recent laboratory results: Submission of recent laboratory results within the past 4 to 12 weeks since the last Injectafer administration to demonstrate need for additional therapy4-12 weeks
Dosing conformity: Injectafer dosing is in accordance with FDA approved labeling for iron deficiency in heart failure
Authorization limit: Continuation authorization will be for no longer than 12 months12 months

Serum ferritin (IDA with CKD)

< 100 ng/mL; if 100-300 ng/mL then TSAT < 20% required

Injectafer heart failure ferritin thresholdSerum ferritin < 100 ng/mL OR ferritin 100-300 ng/mL with TSAT < 20%

Injectafer heart failure LVEF< 45%

Injectafer heart failure Hb< 15 g/dL

Pediatric ferritin (age <12)≤ 15 µg/L

Examples of required documents: serum ferritin, TSAT, hemoglobin, and chart notes documenting prior oral/IV therapy and clinical response.

Documentation Required

Prescriber attestation for superiority or safety

When coverage is based on prior IV therapy failure or intolerance, the prescriber must attest that clinical response with Feraheme or Injectafer would be expected to be superior to the response experienced with the preferred IV products, or that the same intolerance/contraindication/severe adverse event would not be expected to occur with Feraheme or Injectafer.

Documentation Required

Recent labs required for continuation

For continuation requests, submit recent laboratory results obtained within the past 4 to 12 weeks since the last Feraheme or Injectafer administration to demonstrate ongoing need for additional therapy.

Billing Rule

Dosing must follow FDA labeling

Dosing for Feraheme, Injectafer, and Monoferric must be consistent with United States Food and Drug Administration (FDA) approved labeling to meet the policy dosing requirements.