Iron Preparations (Injectable/Intravenous Iron)
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Defines Aloha Care coverage, prior authorization, and clinical criteria for injectable iron products (e.g., Venofer, Ferrlecit, Injectafer, Feraheme, Monoferric, Triferic, Infed) for members, including Medicare Part B considerations and product-specific approval lengths.
No material clinical or coverage changes in this revision.
Coverage and Product Criteria
Coverage criteria (by diagnosis)
Covered when ALL of the following diagnosis-specific laboratory, trial, and other requirements are satisfied (criteria vary by diagnosis and product).
ALL of the following
- Diagnosis: Iron deficiency anemia due to chronic kidney disease (CKD) or an inflammatory condition (e.g., IBD, heart failure).
- Diagnosis: Iron deficiency anemia due to cancer/chemotherapy or non-inflammatory conditions (e.g., blood loss, malabsorption, malnutrition).
- Diagnosis: Iron deficiency anemia in pregnancy.
- Diagnosis: Iron deficiency anemia in hemodialysis-dependent ESRD (for Triferic and dialysis-specific products).
ALL of the following
- For CKD or inflammatory conditions: serum ferritin < 100 ng/mL AND TSAT < 20% OR ferritin <= 500 ng/mL AND TSAT <= 30%.
- For cancer/chemotherapy or non-inflammatory conditions: serum ferritin < 30 ng/mL AND TSAT < 20%.
- For pregnancy: serum ferritin < 30 ng/mL AND TSAT < 20%; additional pregnancy timing/severity rules apply (see pregnancy node).
ALL of the following
- Member has had a 4-week trial of oral iron supplementation with inadequate response or documented intolerance prior to IV/injectable iron (required for most indications).
ALL of the following
- For requests of Feraheme, Injectafer, or Infed: member must have had a trial of, inadequate response to, or intolerance to BOTH Ferrlecit (iron sucrose complex) AND Venofer (iron sucrose).
- For certain indications (per policy), trial of Ferrlecit and Venofer is required prior to other non-preferred agents; for some products (per chunk 10) a trial of Feraheme in addition to Ferrlecit and Venofer may be required.
ALL of the following
- Member is hemodialysis dependent (ESRD dialysis) where applicable.
- Request for certain agents must include prior trial of Ferrlecit and Venofer (step therapy applies to new starts).
ALL of the following
- One of the following must be met for pregnancy: member is past 14 weeks and has had a 4-week trial of oral iron with inadequate response or intolerance; OR member is past 14 weeks with severe iron deficiency anemia (Hgb < 8 g/dL); OR member is past 34 weeks of pregnancy.
- For requests of Feraheme, Injectafer, or Infed in pregnancy: member must have had trial/inadequate response/intolerance to two agents (Ferrlecit AND Venofer).
- For Infed in pregnancy when used: IM administration may be acceptable if venous access precludes IV use (see product-specific rules).
ALL of the following
- If bone marrow demonstrates inadequate iron stores, this satisfies laboratory confirmation requirements where specified.
ALL of the following
- Agents are not approved when the above criteria are not met.
- Venofer is not covered for restless legs syndrome (explicit exclusion).
ALL of the following
- Clinical documentation must include diagnosis, recent labs (ferritin and TSAT within 4 weeks) or bone marrow findings, documentation of oral iron trial or intolerance, and prior IV agent trials when required.
Product dosing and indication nodes
Product-specific indications and dosing/administration details (include weight-based thresholds where specified).
ALL of the following
- Indications: anemia due to and following chemotherapy (with ESA), iron deficiency due to blood loss, iron deficiency anemia.
- Dosing/administration: test dose 25 mg IV push followed by 75–100 mg bolus weekly; total-dose formulas provided (0.0442*(desired Hb - observed Hb)*lean body weight + 0.26*lean body weight); MAX 2 mL (100 mg elemental iron) per day; may be given via slow IV infusion or (INFeD only) deep IM injection; discontinue oral iron prior to use.
- Special: IM administration (Infed) may be used when venous access is not possible (product-specific exception).
ALL of the following
- >=50 kg: 750 mg IV followed by 750 mg IV 7 days later (total 1500 mg per course) OR 15 mg/kg up to a maximum single dose of 1000 mg; <50 kg: 15 mg/kg IV followed by 15 mg/kg IV 7 days later. Treatment may be repeated if anemia recurs.
- Each mL contains 50 mg elemental iron; available vial sizes and cumulative dosing guidance provided in the policy.
ALL of the following
- >=50 kg: 1000 mg IV over at least 20 minutes as a single dose; <50 kg: 20 mg/kg IV over at least 20 minutes as a single dose; repeat dose if anemia recurs.
- Single-dose total 1000 mg for adults >=50 kg (product vial contains 1000 mg).
ALL of the following
- Indication: dependence on hemodialysis due to end stage renal disease; administer at each hemodialysis session.
- Dosing: multiple formulations — e.g., solution 5-mL ampule (27.2 mg per 2.5 gal bicarbonate concentrate), 50-mL ampule (272 mg per 25 gal), powder packet (272 mg per 25 gal); Triferic AVNU solution 4.5 mL IV (6.75 mg) administered at each hemodialysis session for as long as the patient is dialyzed.
ALL of the following
- Policy provides total dose replacement formulas (e.g., 0.0442*(desired Hb - observed Hb)*lean body weight + 0.26*lean body weight) and blood-loss-based calculations; discontinue oral iron prior to IV therapy where specified.
Initial Therapy Requirements
Initial therapy requirements
Initial therapy covered when ALL of the following are met; initial authorization durations and prerequisite therapies are specified below.
ALL of the following
- Initial approval commonly 6 months with renewal for 1 year for many injectable iron therapies (per product-specific rules).
ALL of the following
- Member must have had a 4-week trial of oral iron with inadequate response or documented intolerance prior to initiating IV/injectable iron for most indications.
ALL of the following
- Requests for Feraheme, Injectafer, or Infed require prior trial of Ferrlecit AND Venofer (documented inadequate response or intolerance).
ALL of the following
- Clinical documentation must include diagnosis, labs (ferritin and TSAT within 4 weeks) or bone marrow findings, and evidence of prior oral iron and prior IV agent trials when applicable.
Continuation and Transition
Continuation during Medicare transition
Continuation of active treatment for new Medicare members during the initial enrollment transition.
ALL of the following
- For new Medicare members, during the first 90 days of enrollment, if the member is currently on an active course of the requested treatment, Coverage and Step Therapy do not apply and the treatment is continued.
- After the 90-day transition period, Coverage and Step Therapy Criteria must be met for continued coverage.
Coding (HCPCS)
| J1437 | Injection, ferric derisomaltose, 10 mg (Monoferric) |
| J1439 | Injection, ferric carboxymaltose, 1 mg (Injectafer) |
| J1443 | Injection, ferric pyrophosphate citrate solution (Triferic), 0.1mg of iron |
| J1750 | Injection, iron dextran, 50 mg (Infed) |
| J1756 | Injection, iron sucrose, 1 mg (Venofer) (Preferred) |
| J2916 | Injection, sodium ferric gluconate complex in sucrose injection, 12.5 mg (Ferrlecit) (Preferred) |
| Q0138 | Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg (non-esrd use) (Feraheme) |
Provider Actions, Prior Authorization, and Exclusions
Prior authorization required; typical approval lengths
Prior authorization is required for injectable iron products; initial approvals are generally 6 months with renewals for 1 year. Prior authorization includes PA and quantity limit (QL) overrides noted in the policy.
- PA required for listed HCPCS-coded injectable iron products (see coding table).
- Typical approval length: Initial 6 months; Renewal 1 year.
- PA may include QL overrides per policy.
Medicare Part B 90-day transition and step therapy trials
For new Medicare Part B members, a 90-day transition period applies during which coverage and step therapy do not apply if the member is on an active course of treatment. After 90 days, step therapy requires trial and inadequate response or intolerance to both Ferrlecit and Venofer for new Medicare starts.
- 90-day transition: continue active treatment (including out-of-network) without meeting coverage or step therapy criteria during first 90 days of enrollment.
- Step therapy requirement after transition: trial and inadequate response or intolerance to two agents — Ferrlecit and Venofer — is required for certain non-preferred agents.
Product-specific and general exclusions
Specific exclusions are listed: Venofer is excluded when used for restless legs syndrome; Triferic/Triferic AVNU may not be approved for peritoneal dialysis; and all agents are not approved when the policy criteria are not met.
- Venofer (iron sucrose) — not covered for restless legs syndrome.
- Triferic/Triferic AVNU (ferric pyrophosphate citrate) — may not be approved for peritoneal dialysis.
- All agents — not approved when the above coverage criteria are not met or for other non-specified indications.
Follow AlohaCare/Carelon Rx prior authorization criteria
This policy references the AlohaCare/Carelon Rx prior authorization criteria for Iron Preparations; providers should use those PA criteria when completing prior authorization requests.
- See: Iron Preparations - AlohaCare/Carelon Rx, PA criteria (referenced in policy).
Laboratory and Dose Definitions
Step Therapy Requirements
| Step therapy requirement | Applies to (agents) | Required prior trials | Failure criteria |
|---|---|---|---|
| Step therapy requirement | Feraheme, Injectafer, Infed (and certain requests for other non-preferred agents) | Trial of both Ferrlecit (sodium ferric gluconate) AND Venofer (iron sucrose) | Documented inadequate response or intolerance to both required agents |
| Medicare Part B new starts | Applies to new Medicare starts only | Trial of both Ferrlecit AND Venofer prior to coverage of listed non-preferred agents | Step therapy requirement does not apply during the 90-day Medicare transition period for new members (see continuation rules) |
| Additional step therapy for some indications | Requests for certain indications (e.g., non-ESRD cancer/chemo or other conditions) may require broader trials | Some requests (per policy) may also require trial of Feraheme in addition to Ferrlecit and Venofer | Documented inadequate response or intolerance to all listed prior agents as specified in the criteria |
Quantity Limits and Single-Dose Amounts
Site of Care and Administration
Site-of-care: office, infusion center, outpatient, or home
IV iron products are administered in outpatient settings including physician offices, infusion centers, hospital outpatient departments, or at home depending on product and clinical circumstances; Infed may be given by deep IM injection when venous access precludes IV administration.
- Settings: office, infusion center, hospital outpatient, or home as appropriate per product.
- Infed (iron dextran) may be administered via deep IM injection (INFeD) if IV access is not feasible.
Infusion timing: Monoferric infusion time and Triferic during hemodialysis
Follow product-specific infusion timing and operational instructions: Monoferric should be administered as a single IV dose over at least 20 minutes for patients ≥50 kg, and Triferic is delivered during each hemodialysis session (or added to bicarbonate concentrate) per dialysis-center procedures.
- Monoferric dosing: ≥50 kg — 1000 mg IV over at least 20 minutes as a single dose.
- Triferic administration: give at each hemodialysis session or add appropriate ampule to bicarbonate concentrate per product instructions.
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