CurrentBlue Cross Blue Shield - IowaPolicy 05.05.58

Intravenous Iron Product Benefit Application (Preferred vs Non-Preferred)

Defines preferred versus non-preferred intravenous iron products for benefit determination and describes exception criteria and prior authorization requirements for non-preferred products for Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyIntravenous Iron Product Benefit Application (Preferred vs Non-Preferred)

Policy CodePolicy 05.05.58

Change TypeNo material change

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain prior authorization and documentation demonstrating one exception criterion to request coverage for non-preferred intravenous iron products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4preferred products listed

1non-preferred listed

6billing codes

2ferumoxytol codes

Coverage Criteria and Policy Scope

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This policy applies only when the member’s benefit for intravenous iron exists and is not excluded or limited by the member’s contract. Benefit determinations are based on the applicable contract language in effect at the time services were rendered; exclusions, limitations, or exceptions may apply. Wellmark (Blue Cross Blue Shield - Iowa) will determine medical necessity only if the benefit exists and no contract exclusions are applicable.

Exception Criteria for Non-Preferred Products

Preferred products are covered without prior authorization. Coverage for non-preferred products is provided when ONE of the following is met:

Exception Criteria: Member has had a documented inadequate response, intolerable adverse event, or a contraindication to the preferred products

Supports coverage of non-preferred product

Continuation/Existing Therapy: Member is currently receiving therapy with a non-preferred product and is experiencing a positive therapeutic outcome

Allows continuation of an existing non-preferred therapy

Continuation Therapy

Continuation therapy

Continuation of current non-preferred therapy may be approved when there is documented positive therapeutic outcome.

Continuation: Member is currently receiving therapy with a non-preferred product and is experiencing a positive therapeutic outcome

Supports exception for continuation

Prior Authorization and Documentation Requirements

Denial Risk

Denial Risk — Verify Benefits

Services may be denied if the benefit for the requested service does not exist in the member's contract, or if exclusions or limitations apply. Verify member benefits and contract terms prior to submitting a request.

Benefits are determined by the applicable contract in effect at the time of service
Exclusions, limitations, or exceptions may apply
Medical necessity is determined only if the benefit exists and no contract exclusions are applicable

Prior Authorization

Prior Authorization Required for Non‑Preferred Products

Prior authorization is required for non-preferred intravenous iron products. Preferred products (Feraheme, Ferrlecit, Infed, and Venofer) are considered medically necessary and do not require prior authorization.

Preferred products do not require prior authorization: Feraheme, Ferrlecit, Infed, Venofer
Non-preferred intravenous iron products require prior authorization

Documentation Required

Documentation Required for Non‑Preferred Product Requests

When requesting coverage for a non-preferred intravenous iron product, submit documentation demonstrating that ONE of the exception criteria is met: documented inadequate response, intolerable adverse event, or contraindication to preferred products; or the member is currently receiving the non-preferred product with demonstrated positive therapeutic outcome.

Documented inadequate response to preferred products
Documented intolerable adverse event to preferred products
Documented contraindication to preferred products
Member currently receiving non-preferred product with positive therapeutic outcome

Procedures and Billing Codes

Procedures/Billing codesmixed

J1437	injection, ferric derisomaltose (Monoferric), 10 mg
J1439	injection, ferric carboxymaltose (Injectafer), 1 mg
J1750	injection, iron dextran (Infed), 50 mg
J1756	injection, iron sucrose (Venofer), 1 mg
J2916	injection, sodium ferric gluconate complex (Ferrlecit), 12.5 mg
Q0138	injection, ferumoxytol (Feraheme), 1 mg (non-esrd)
Q0139	injection, ferumoxytol (Feraheme), 1 mg (for esrd on dialysis)

Step Therapy / Product Selection Rules

Requirement	Details
Must meet one of the exception criteria to receive a non-preferred product	Coverage for a non-preferred product is provided when ONE of the following is met: (1) Member has had a documented inadequate response, intolerable adverse event, or a contraindication to the preferred products; or (2) Member is currently receiving therapy with a non-preferred product and is experiencing a positive therapeutic outcome.

Definitions — Preferred and Non-Preferred Products

inv-09: Preferred products — Listed intravenous iron formulations considered medically necessary and not requiring prior authorization.

Preferred products (medically necessary)Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate), Infed (iron dextran), Venofer (iron sucrose) — these products are considered medically necessary and do not require prior authorization.

ApplicabilityThis designation applies to intravenous iron products specified in the policy for all members requesting treatment.

Coverage implicationPreferred products are covered without prior authorization under this policy.

inv-10: Non-preferred products — Targeted intravenous iron formulations that require an exception (prior authorization) for coverage unless exception criteria are met.

Non-preferred product listedInjectafer (ferric carboxymaltose) is designated as a targeted/non-preferred product.

Exception criteria for coverageCoverage for a non-preferred product is provided when ONE of the following is met: documented inadequate response, intolerable adverse event, or contraindication to the preferred products; OR the member is currently receiving the non-preferred product with a positive therapeutic outcome.

Prior authorization requirementNon-preferred products require prior authorization; coverage review will ascertain situations where a clinical exception can be made.

Site of Care and Dosing Limits

Billing Rule

Infusion center approvals subject to dosing limits

Approvals for infusion center administration may be subject to dosing limits consistent with FDA-approved labeling, accepted compendia, or evidence-based practice guidelines.

Dosing and administration must align with FDA labeling, compendia, or guideline-based limits.

Background and Clinical Context

Intravenous iron formulations are used to treat iron deficiency when oral iron is inadequate or inappropriate. This policy distinguishes between preferred products — the intravenous iron formulations considered medically necessary for initiation and not requiring prior authorization (Feraheme, Ferrlecit, Infed, and Venofer) — and non-preferred/targeted products (for example, Injectafer/ferric carboxymaltose) that require an exception and prior authorization for coverage unless specific criteria are met.

Coverage for a non-preferred product may be granted only when one of the policy’s exception criteria is met (documented inadequate response to preferred products, intolerable adverse event, or contraindication), or when the member is already receiving a non-preferred product and has a documented positive therapeutic outcome. Approvals for any intravenous iron product may be subject to dosing limits consistent with FDA labeling, accepted compendia, and evidence-based practice guidelines.