Colorado Rocky Mountain Health Plans IV Iron Coverage

Medically Necessary Criteria

Medically Necessary — IDA Without CKD (Initial Therapy)

Feraheme, Injectafer, and Monoferric are medically necessary when ALL of the following are met:

ALL of the following

Submission of medical records (e.g., lab values, chart notes) supporting diagnosis of iron deficiency anemia (IDA)
Patient does NOT have chronic kidney disease (CKD)
One of the following
- History of failure, contraindication, or intolerance to oral iron therapy
- Or one of the following clinical scenarios
  - Severe iron deficiency in late stage pregnancy
  - Impaired absorption due to prior gastric surgery or gastrointestinal disorder (e.g., celiac disease, inflammatory bowel disease)
  - Blood loss exceeds the ability to replete iron orally
And one of the following for use of non-preferred IV products
- Option A
  - Submission of laboratory values demonstrating treatment failure to at least two of the following intravenous iron therapies: Ferrlecit (sodium ferric gluconate), Infed (iron dextran), Venofer (iron sucrose)
    Lab values should be obtained within 4 to 12 weeks following the last dose of intravenous iron in a treatment course.
  - Prescriber attests that clinical response with Feraheme, Injectafer, or Monoferric would be expected to be superior to response with preferred IV iron products
- Option B
  - History of intolerance, contraindication, or severe adverse event to ALL of the following intravenous iron therapies: Ferrlecit AND Infed AND Venofer
  - Prescriber attests that the same intolerance/contraindication/severe adverse event would NOT be expected to occur with Feraheme, Injectafer, or Monoferric
Dosing is in accordance with FDA-approved labeling
Initial authorization limited to no longer than 12 months

Medically Necessary — IDA Without CKD (Continuation Therapy)

For continuation of Feraheme, Injectafer, or Monoferric when previously authorized:

ALL of the following

Prior coverage was previously provided by UnitedHealthcare for the same agent for IDA based on documented history of either intolerance/contraindication/severe adverse event to all three preferred IV products OR treatment failure of at least two of the three preferred IV products
Submission of recent laboratory results (within past 4 to 12 weeks since last administration) to demonstrate ongoing need for additional therapy
Submission of recent laboratory results (within the past 4 to 12 weeks) since the last administration to demonstrate ongoing need.
Patient does NOT have CKD
Dosing is in accordance with FDA-approved labeling

Medically Necessary — IDA With CKD (Non-ESRD) (Initial Therapy)

Feraheme, Injectafer, and Monoferric are medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of iron deficiency anemia and chronic kidney disease (CKD)
Submission of medical records supporting IDA diagnosis
Patient does NOT have end stage renal disease (ESRD)
One of the following high-level paths
- Patient on dialysis
  - Patient's CKD requires hemodialysis or peritoneal dialysis treatment

Medically Necessary — IDA With CKD (Non-ESRD) (Continuation Therapy)

For continuation when previously authorized for IDA with CKD:

ALL of the following

Prior UnitedHealthcare coverage for the same agent based on documented intolerance/contraindication/severe adverse event to all three preferred IV products OR treatment failure of at least two of the three preferred IV products
Patient does NOT have ESRD
Submission of recent laboratory results (within past 4 to 12 weeks since last administration) to demonstrate ongoing need for additional therapy
Submission of recent laboratory results (within the past 4 to 12 weeks) since the last administration to demonstrate ongoing need for additional therapy.
Dosing is in accordance with FDA-approved labeling

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

Injectafer is medically necessary to improve exercise capacity in adult patients with heart failure NYHA class II/III when ALL of the following are met:

ALL of the following

Submission of medical records supporting diagnosis of iron deficiency defined by either: Serum ferritin < 100 ng/mL; OR Serum ferritin 100–300 ng/mL AND TSAT < 20%
Hemoglobin (Hb) < 15 g/dL
One of the following for use after trying preferred IV products
- Option A (treatment failure)
  - Submission of laboratory values demonstrating treatment failure to at least two of: Ferrlecit, Infed, Venofer
    Labs within 4 to 12 weeks after last dose.

Relevant Codes

J-codes / HCPCS for IV ironHCPCS

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 referencedICD-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/without specified stages
I13.0	Hypertensive heart and chronic kidney disease with heart failure
I13.10	Hypertensive heart and chronic kidney disease without heart failure
I50.1	Left ventricular failure, unspecified
I50.20	Unspecified systolic (congestive) heart failure

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Prior Authorization, Documentation & Denial Risks

Prior Authorization

Prior authorization required with documentation

Prior authorization is required for J1437, J1439, Q0138, and Q0139. Providers must submit medical records (e.g., lab values, chart notes) supporting the diagnosis of iron deficiency anemia and, for use of non-preferred IV products, either laboratory evidence of treatment failure to preferred IV products or documentation of intolerance/contraindication to all preferred IV products. A prescriber attestation is required when asserting expected superiority of the requested agent or absence of cross‑reactive intolerance.

Affected HCPCS/J‑codes: J1437, J1439, Q0138, Q0139
Submit medical records (lab values, chart notes) supporting IDA diagnosis
For non‑preferred IV use: submit labs showing failure to preferred IVs OR documentation of intolerance/contraindication to all preferred IVs
Include prescriber attestation of expected superior response or lack of cross‑reactive intolerance

Documentation Required

Clinical Rationale and Context

Intravenous (IV) iron formulations—ferumoxytol (Feraheme), ferric carboxymaltose (Injectafer), and ferric derisomaltose (Monoferric)—are indicated for treatment of iron deficiency anemia (IDA) when oral iron is not tolerated, has produced an unsatisfactory response, or when clinical conditions (for example, chronic kidney disease or prior gastric surgery) limit absorption and make oral therapy ineffective. The policy specifies these agents as options when oral therapy fails or is contraindicated and highlights that IV therapy can rapidly replete iron stores and may require only one or two infusions with newer formulations.

Before using non-preferred IV products (Feraheme, Injectafer, Monoferric), the policy expects trials of preferred comparator IV iron products—Ferrlecit (sodium ferric gluconate), Infed (iron dextran), and Venofer (iron sucrose)—unless there is documented intolerance, contraindication, or severe adverse event to those agents, or documented failure of at least two of them. Prescriber attestation is required when asserting that a non-preferred product would be expected to provide superior clinical response or would avoid a prior intolerance noted with preferred agents.

Laboratory markers used to define and guide therapy are serum ferritin and transferrin saturation (TSAT). Diagnostic thresholds differ by CKD status: for adults and patients ≥ 12 years without CKD, IDA is defined as serum ferritin < 30 ng/mL or TSAT < 20% (or absence of stainable iron in bone marrow). For IDA associated with CKD (non-ESRD), iron deficiency is defined as serum ferritin < 100 ng/mL or TSAT < 20%, and when ferritin is 100–300 ng/mL a TSAT < 20% is required to confirm iron deficiency.

Where IV therapy is pursued after prior IV products, laboratory evidence of treatment failure must be documented with tests obtained within a specified window: laboratory values should be obtained within 4 to 12 weeks following the last dose of an IV iron treatment course. This timing requirement applies to both initial requests asserting failure of preferred IV products and to continuation requests to demonstrate ongoing need.

Key Diagnostic & Operational Thresholds

Laboratory window for demonstrating IV treatment failureLaboratory values should be obtained within 4 to 12 weeks following the last dose of intravenous iron in a treatment course

Injectafer — iron deficiency diagnostic thresholds (heart failure)Serum ferritin < 100 ng/mL OR (Serum ferritin 100–300 ng/mL AND TSAT < 20%); Hemoglobin < 15 g/dL

IDA without CKD — adult diagnostic thresholdsAdults and patients ≥ 12 years: Serum ferritin < 30 ng/mL OR TSAT < 20% OR absence of stainable iron in bone marrow

IDA with CKD — diagnostic thresholdsSerum ferritin < 100 ng/mL OR TSAT < 20%; if ferritin 100–300 ng/mL then TSAT < 20% required

Continuation/authorization durationAuthorization up to 12 months (initial and continuation)

Defined Terms

IDA Without CKDAdults and pediatric patients ≥ 12 years: Serum ferritin < 30 ng/mL or TSAT < 20% or absence of stainable iron in bone marrow; pediatric < 12 years: hemoglobin below age cutoffs plus ferritin ≤ 15 µg/L or reticulocyte hemoglobin measures supporting IDA.

IDA With CKD, Without ESRDSerum ferritin < 100 ng/mL or TSAT < 20%. If ferritin is 100–300 ng/mL, TSAT < 20% is required to confirm iron deficiency.

Preferred IV iron products (comparators)Ferrlecit (sodium ferric gluconate complex), Infed (iron dextran), and Venofer (iron sucrose).

Policy Changes

2026-04-01Template updateLatest

Policy template updated; content/language pertaining to Louisiana removed and previous policy version CS2026D0088P archived.

OpenPayer

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

Medically Necessary Criteria

Relevant Codes

Prior Authorization, Documentation & Denial Risks

Clinical Rationale and Context

Key Diagnostic & Operational Thresholds

Defined Terms

Policy Changes