amerihealth
Advanced Search

Intravenous (IV) Iron Preparations
MA08.150a

Policy

In the absence of coverage criteria from applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, or other Medicare coverage documents, this policy uses internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, and/or regulatory status. ​

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

COMPANY-DESIGNATED PREFERRED PRODUCTS

Although there are many brands of intravenous (IV) iron products on the market for the treatment of iron deficiency (ID) or ​iron-deficiency anemia (IDA), there is no reliable evidence of the superiority of any one brand of IV iron product compared with other brands. The Company has designated preferred IV iron products for use in nonpregnant adults aged 18 years and older. The COMPANY-DESIGNATED PREFERRED IRON PRODUCTS are less costly and at least as likely to produce equivalent therapeutic results as the nonpreferred IV iron products. 

Note: The use of preferred products does not apply for individuals under age 18 years or for use in pregnant individuals. 

COMPANY-DESIGNATED PREFERRED IRON PRODUCTS

COMPANY-DESIGNATED NONPREFERRED IRON PRODUCTS*

Ferumoxytol (e.g., Feraheme®)

Ferric carboxymaltose (e.g., Injectafer®)

Sodium ferric gluconate complex in sucrose (e.g., Ferrlecit®)

Ferric derisomaltose (e.g., Monoferric®)

Iron dextran (e.g., INFeD®)

 

Iron sucrose (e.g., Venofer®)

 


COMPANY-DESIGNATED NONPREFERRED PRODUCTS*

Use of the COMPANY-DESIGNATED NONPREFERRED IV iron preparations is eligible for coverage only for individuals who are currently receiving, or have previously received, a COMPANY-DESIGNATED NONPREFERRED PRODUCT for the specified indication.

If the individual has not previously received the COMPANY-DESIGNATED NONPREFERRED IV iron preparations to treat the specified indication, the nonpreferred product is eligible for coverage when the individual has documentation of a contraindication, intolerance (e.g., as documented per the FDA labeling), or inadequate response to TWO OR MORE ​Company-designated preferred products.​​

Note: Use of nonpreferred product samples administered by the professional provider will not meet coverage criteria for the exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting provider ​for review.

MEDICALLY NECESSARY (ADULT INDIVIDUALS)

MANAGEMENT OF HEART FAILURE
The use of ferric carboxymaltose (e.g., Injectafer) for the treatment of adult individuals with New York Heart Association class II/III heart failure is considered medically necessary and, therefore, covered without the need to try any preferred IV iron products to improve exercise capacity.
 
MANAGMENT OF IRON DEFICIENCY OR IRON DEFICIENCY ANEMIA WITHOUT CHRONIC KIDNEY DISEASE
The use of a non-preferred IV iron product, for the treatment of iron deficiency (ID) or iron deficiency anemia (IDA) without chronic kidney disease (CKD), is considered medically necessary and, therefore, covered for adult individuals with ALL of the following:
  • Individual has met the requirements listed in the COMPANY-DESIGNATED PREFERRED PRODUCTS and NONPREFERRED PRODUCTS sections above
  • Ferritin level less than 30 n​g/mL OR transferrin saturation (TSAT) less than 20% (not ​required for pregnant individuals)
  • Normal kidney function as demonstrated by laboratory values (e.g., urine albumin, creatinine, glomerular filtration ratio [GFR])
  • Documented intolerance, contraindication, or nonresponse to oral iron supplementation for at least 3 months
MANAGMENT OF IRON DEFICIENCY OR IRON DEFICIENCY ANEMIA WITH CHRONIC KIDNEY DISEASE
The use of a non-preferred IV iron product, for the treatment of ID or IDA with CKD, is considered medically necessary and, therefore, covered for adult individuals with ALL of the following:
  • Individual has met the requirements listed in the COMPANY-DESIGNATED PREFERRED PRODUCTS and NONPREFERRED PRODUCTS sections above
  • ONE of the following (not ​required for pregnant individuals):
    • Ferritin level 100 ng/mL or less AND TSAT less than 20% in nondialysis individuals or those receiving peritoneal dialysis 
    • Ferritin level  200 ng/mL or less AND TSAT less than 20% in individuals on hemodialysis 
  • CKD as demonstrated by abnormal laboratory values (e.g., urine albumin, creatinine, GFR)
  • Documented intolerance, contraindication, or nonresponse to oral iron supplementation for at least 3 months
MANAGEMENT OF CANCER- AND CHEMOTHERAPY-INDUCED ANEMIA
The use of a non-preferred IV iron product, for the treatment of cancer- and chemotherapy-induced anemia, is considered medically necessary and, therefore, covered for adult individuals who have met the requirements listed in the COMPANY-DESIGNATED PREFERRED PRODUCTS and NONPREFERRED PRODUCTS sections above, and​ with EITHER of the following:
  • For the treatment of EITHER of the following:
    • Absolute iron deficiency (ferritin <30 ng/mL and transferrin saturation <20%)
    • Possible functional iron deficiency (ferritin >500–800 ng/mL and transferrin saturation <50%) in selected individuals (with the goal of avoiding allogeneic transfusion)
  • In combination with erythropoiesis-stimulating agents (ESAs) for the treatment of EITHER of the following:
    • Functional iron deficiency (ferritin 30–​500 ng/mL and transferrin saturation <50%) in individuals receiving myelosuppressive chemotherapy without curative intent and ESAs
    • Absolute iron deficiency (ferritin <30 ng/mL and transferrin saturation <20%) in individuals who do not experience an increase in hemoglobin after 4 weeks of IV or oral iron supplementation​
NOT MEDICALLY NECESSARY (ADULT INDIVIDUALS)

The use of non-preferred products that do not meet the conditions listed under the COMPANY-DESIGNATED PREFERRED PRODUCTS and COMPANY-DESIGNATED NONPREFERRED PRODUCTS sections above, in adult individuals aged 18 years and older, is considered not medically necessary and, therefore, not covered since they are more costly than the preferred products that are at least as likely to produce equivalent therapeutic results.

MEDICALLY NECESSARY (PEDIATRIC INDIVIDUALS)

Ferric carboxymaltose (e.g., Injectafer), as an IV infusion, is considered medically necessary and, therefore, covered for the treatment of IDA in pediatric individuals 1 year of age and older who meet ALL of the following:
  • Individual has a documented diagnosis of IDA and has normal kidney function 
  • Individual has ONE of the following:
    • Intolerance to oral iron
    • An unsatisfactory response to oral iron
    • A contraindication to oral iron (examples: inflammatory bowel disease, peptic ulcer disease, history of bowel surgery) 
  • Dosing and frequency is in accordance with US Food and Drug Administration (FDA) labeling 
Iron dextran (e.g., INFeD), as an IV infusion, is considered medically necessary and, therefore, covered for the treatment of ID or IDA in pediatric individuals 4 months of age and older who meet ALL of the following:
  • Individual has a documented diagnosis of ID or IDA
  • Individual has ONE of the following:
    • Intolerance to oral iron
    • An unsatisfactory response to oral iron
    • A contraindication to oral iron (examples: inflammatory bowel disease, peptic ulcer disease, history of bowel surgery) 
  • Dosing and frequency is in accordance with FDA labeling
Iron sucrose (e.g., Venofer) as an IV infusion, is considered medically necessary and, therefore, covered for the treatment of IDA in pediatric individuals 2 years of age and older who meet BOTH of the following:
  • Individual has a documented diagnosis of BOTH of the following:
    • IDA on erythropoietin therapy for iron maintenance
    • ONE of the following types of CKD:
      • Hemodialysis-dependent CKD (HDD-CKD)
      • Nondialysis-dependent CKD (NDD-CKD)
      • Peritoneal dialysis-dependent CKD (PDD-CKD)
  • Dosing and frequency is in accordance with FDA labeling
Sodium ferric gluconate complex in sucrose (e.g., Ferrlecit) as an IV infusion, is considered medically necessary and, therefore, covered for the treatment of IDA in pediatric individuals 6 years of age and older who meet ALL of the following:
EXPERIMENTAL/INVESTIGATIONAL

All other uses for intravenous iron are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information on ferumoxytol (Feraheme) and iron dextran (INFeD) for any applicable Black Box warnings.
 
BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, intravenous iron is covered under the medical benefits of the Company's Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION STATUS

Ferric carboxymaltose (Injectafer) was approved by the US Food and Drug Administration (FDA) on July 25, 2013, for the treatment of iron deficiency anemia (IDA) in adult individuals who have intolerance to or have unsatisfactory response to oral iron or individuals who have non-dialysis dependent chronic kidney disease (CKD). Supplemental approvals for ferric carboxymaltose (Injectafer) have since been issued by the FDA.

Ferric derisomaltose (Monoferric) was approved by the FDA on January 16, 2020, for the treatment of IDA in adult individuals who have intolerance to or have had unsatisfactory response to oral iron or individuals who have non-hemodialysis dependent chronic kidney disease.

Ferumoxytol (Feraheme) was approved by the FDA on June 30, 2009, for the treatment of IDA in adult individuals with CKD. Supplemental approvals for ferumoxytol (Feraheme) have since been issued by the FDA.

Iron dextran (INFeD) was approved by the FDA on August 12, 2009, for the treatment of individuals with documented iron deficiency in whom oral administration is unsatisfactory or impossible. Supplemental approvals for iron dextran (INFeD) have since been issued by the FDA.

Iron sucrose (Venofer) was approved by the FDA on November 6, 2000, for the treatment of IDA in individuals undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy. Supplemental approvals for iron sucrose (Venofer) have since been issued by the FDA.

Sodium ferric gluconate complex in sucrose (Ferrlecit) was approved by the FDA on February 18, 1999, for the treatment of iron deficiency in individuals undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy. Supplemental approvals for sodium ferric gluconate complex in sucrose (Ferrlecit) have since been issued by the FDA.

PEDIATRIC USE
The safety and effectiveness of ferric derisomaltose (Monoferric) in pediatric individuals have not been established.

The safety and effectiveness of ferumoxytol (Feraheme) in pediatric individuals less than 18 years old have not been established.

BILLING GUIDELINES

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Description

Iron is absorbed from the gastrointestinal (GI) tract from food and stored in the liver in the form of ferritin. When needed by the body, the ferritin is released into the bone marrow to help make new red blood cells. When the red blood cells reach the end of their life cycle and undergo hemolysis, iron from those cells can be recycled and reused. If iron stores become depleted, either due to loss of blood, lack of adequate iron intake in the diet, or the lack of the body to absorb iron from the GI tract, iron-deficiency anemia (IDA) can occur. This can result in inadequate provision of oxygen to the body tissues and organs leading to multiple health issues. Although there can be other causes of anemia, IDA is the most common cause worldwide. The estimated prevalence of IDA in North America is 2.9%.

Common causes of IDA can include menstruation, pregnancy, breastfeeding, chronic kidney disease (CKD), major surgery, physical trauma, GI diseases (ulcerative colitis, Crohn disease, celiac disease, peptic ulcer disease), GI malignancies, bariatric procedures, and vegetarian or vegan diets. There are multiple other less common causes of IDA as well. Efforts to identify and treat the cause(s) are necessary.

Blood tests are used to diagnose IDA. Results of laboratory tests will demonstrate the following: low hemoglobin (hgb), low mean cellular volume (MCV), low serum iron, low ferritin, low iron saturation, high transferrin, and high total iron-binding capacity (TIBC). When an individual is found to be anemic, as demonstrated by a low hgb, the next step is to look at the ferritin levels. There are different recommendations for the cut-off value for serum ferritin levels to define IDA proposed by different professional societies. The World Health Organization (WHO) recommends less than 12 ng/mL for healthy individuals under the age of 5 years, and less than 15 ng/mL for healthy individuals ages 5 years and above. For individuals with infection or inflammation, the levels increase to less than 30 ng/mL and less than 70 ng/mL for the same groups. The National Heart, Lung, and Blood Institute (NHLBI) recommend a cut-off level for ferritin at less than 10 ng/mL. The American Gastroenterological Association (AGA) recommends a cut-off level for ferritin at less than 45 ng/mL.

Once IDA has been identified, treatment can begin. Identifying the cause of the IDA can occur at the same time that the IDA is being treated. Treatment is usually begun with oral iron supplementation. If the individual is unable to tolerate oral iron supplementation, has a documented contraindication to oral iron supplementation, or has a documented nonresponse to oral iron supplementation, then erythropoiesis-stimulating agents (ESAs) and/or intravenous (IV) iron can be ordered. ESAs work by helping the bone marrow make more red blood cells (RBCs). Individuals who are on hemodialysis for end-stage renal disease (ESRD) can receive these medications while they are undergoing their dialysis treatments. If the anemia is severe enough that the individual has symptoms (e.g., fatigue, weakness, dizziness, lightheadedness), then the individual may require transfusions of blood products.

Ferric carboxymaltose (Injectafer) is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

Ferric derisomaltose (Monoferric) is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

Ferumoxytol (Feraheme) consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate  complex enters the reticuloendothelial system macrophages of the liver, spleen, and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

Iron dextran (INFeD) is a complex of ferric hydroxide and dextran that releases iron into the circulation in order to replenish hemoglobin and depleted iron stores.

Iron sucrose (Venofer) is an aqueous complex of polynuclear iron (III) hydroxide in sucrose. Following intravenous administration, iron sucrose (Venofer) is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.

Sodium ferric gluconate complex in sucrose (Ferrlecit) is a stable macromolecular complex and is used to replete the body content of iron.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

Adkinson NF, Strauss WE, Macdougall IC, et al. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: a randomized trial. Am J Hematol. 2018;93(5):683-690.

American Hospital Formulary Service (AHFS). Ferric carboxymaltose (Injectafer®). AHFS Drug Information. [UpToDate Lexidrug Web site]. 02/04/2025. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025. 

American Hospital Formulary Service (AHFS). Ferric derisomaltose (Monoferric®). AHFS Drug Information. [UpToDate Lexidrug Web site]. 08/21/2025. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

American Hospital Formulary Service (AHFS). Ferumoxytol (Feraheme®). AHFS Drug Information. [UpToDate Lexidrug Web site]. 02/04/2025. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

American Hospital Formulary Service (AHFS). Iron dextran (INFeD®). AHFS Drug Information. [UpToDate Lexidrug Web site]. 02/04/2025. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

American Hospital Formulary Service (AHFS). Iron sucrose (Venofer®). AHFS Drug Information. [UpToDate Lexidrug Web site]. 02/04/2025. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

American Hospital Formulary Service (AHFS). Sodium ferric gluconate complex in sucrose (Ferrlecit®). AHFS Drug Information. [UpToDate Lexidrug Web site]. 02/04/2025. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

American Society of Hematology (ASH). Iron-deficiency anemia. [ASH Web site]. Available at:  https://www.hematology.org/education/patients/anemia/iron-deficiency. Accessed September 24, 2025.

Revised Auerbach M, DeLoughery TG. Diagnosis of iron deficiency and iron deficiency anemia in adults. [UpToDate Web site]. 07/17/2025. Available at: https://www.uptodate.com/contents/diagnosis-of-iron-deficiency-and-iron-deficiency-anemia-in-adults?search=Causes and diagnosis of iron deficiency and iron deficiency anemia in adults&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. [via subscription only]. Accessed September 24, 2025.

Berns JS. Diagnosis of iron deficiency in chronic kidney disease. [UpToDate Web site]. 03/12/2024. Available at:  https://www.uptodate.com/contents/diagnosis-of-iron-deficiency-in-chronic-kidney-disease?search=diagnosis of iron deficiency anemia&topicRef=7150&source=see_link [via subscription only]. Accessed September 24, 2025. 

Charytan C, Bernardo MV, Kock TA, et al. Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study. Nephrol Dial Transplant. 2013;28(4):953-964.

Elsevier's Clinical Pharmacology Compendium. Ferric carboxymaltose (Injectafer®). [Clinical Key Web site]. 06/17/2025. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed September 24, 2025.

Elsevier's Clinical Pharmacology Compendium. Ferric derisomaltose (Monoferric®). [Clinical Key Web site]. 06/17/2025. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed September 24, 2025.

Elsevier's Clinical Pharmacology Compendium. Ferumoxytol (Feraheme®). [Clinical Key Web site]. 08/20/2025. Available at:  https://www.clinicalkey.com/#!/ [via subscription only]. Accessed September 24, 2025.

Elsevier's Clinical Pharmacology Compendium. Iron dextran (INFeD®). [Clinical Key Web site]. 06/17/2025. Available at:  https://www.clinicalkey.com/#!/ [via subscription only]. Accessed September 24, 2025.

Elsevier's Clinical Pharmacology Compendium. Iron sucrose (Venofer®). [Clinical Key Web site]. 08/06/2025. Available at:  https://www.clinicalkey.com/#!/ [via subscription only]. Accessed September 24, 2025.

Elsevier's Clinical Pharmacology Compendium. Sodium ferric gluconate complex in sucrose (Ferrlecit®). [Clinical Key Web site]. 08/21/2025. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed September 24, 2025.

Ferric carboxymaltose (Injectafer®). 01/2025. Prescribing information. Available at: https://daiichisankyo.us/prescribing-information-portlet/getDocument?product=IF&inline=true. Accessed September 24, 2025.

Fishbane S, Bolton WK, Winkelmayer WC, et al. Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients. Clin Nephrol. 2012;78(3):181-188.

Goldstein SL, Morris D, Warady BA. Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial. Am J Kidney Dis. 2013;61(4):588-597.

Hetzel D, Strauss WE, Bernard K, et al. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014;89(6):646-650.

Ko CW, Siddique SM, Patel A, et al. AGA clinical practice guidelines on the gastrointestinal evaluation of iron deficiency anemia. Gastroenterology. 2020;159(3):1085-1094.

Macdougall IC, Strauss WE, Dahl NV, et al. Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis: the FACT randomized controlled trial. Clin Nephrol. 2019;91(4):237-245.

Macdougall IC, Strauss WE, McLaughlin J, et al. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD. Clin J Am Soc Nephrol. 2014;9(4):705-712.

Merative Micromedex® DRUGDEX® (electronic version). Ferric carboxymaltose (Injectafer®), ferric derisomaltose (Monoferric®), iron dextran (INFeD®), iron sucrose (Venofer®), sodium ferric gluconate complex in sucrose (Ferrlecit®). [Micromedex Web site]. 08/20/2025. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed September 24, 2025.

Merative Micromedex® DRUGDEX® (electronic version). Ferumoxytol (Feraheme®). [Micromedex Web site]. 08/20/2025. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed September 24, 2025.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology®. Hematopoietic Growth Factors V1.2025. [NCCN Web site]. 10/11/2024. Available at:  https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf. [via subscription only]. Accessed September 24, 2025.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium®. [NCCN Web site]. Ferric carboxymaltose (Injectafer®), ferric derisomaltose (Monoferric®), ferumoxytol (Feraheme®), iron dextran (INFeD®), iron sucrose (Venofer®), sodium ferric gluconate complex in sucrose (Ferrlecit®). Available at:  https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed September 24, 2025.

National Heart, Lung, and Blood Institute (NHLBI). Iron-deficiency anemia. [NHLBI Web site]. 03/24/2022. Available at:  https://www.nhlbi.nih.gov/health/anemia/iron-deficiency-anemia. Accessed September 24, 2025.

Onken JE, Bregman DB, Harrington RA, et al. A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia. Transfusion. 2014;54(2):306-315.

Onken JE, Bregman DB, Harrington RA, et al. Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial. Nephrol Dial Transplant. 2014;29(4):833-842.

Ponikowski P, van Veldhuisen DJ, Comin-Colet J, et al. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Eur Heart J. 2015;36(11):657-668.

Provenzano R, Schiller B, Rao M, et al. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009;4(2):386-393.

Short MW, Domagalski JE. Iron deficiency anemia: evaluation and management. Am Fam Physician. 2013;87(2):98-104.

Singh H, Reed J, Noble S, et al. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006;1(3):475-482.

Strauss WE, Dahl NV, Lau G, Allen FL. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016;16:20.

UpToDate® LexidrugTM. Ferric carboxymaltose (Injectafer®). [UpToDate Lexidrug Web site]. 08/12/2025. Available at:  https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

UpToDate® LexidrugTM. Ferric derisomaltose (Monoferric®). [UpToDate Lexidrug Web site]. 08/26/2025. Available at:  https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

UpToDate® LexidrugTM. Ferumoxytol (Feraheme®). [UpToDate Lexidrug Web site]. 08/12/2025. Available at:  https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

UpToDate® LexidrugTM. Iron dextran (INFeD®). [UpToDate Lexidrug Web site]. 08/06/2025. Available at:  https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

UpToDate® LexidrugTM. Iron sucrose (Venofer®). [UpToDate Lexidrug Web site]. 08/22/2025. Available at:  https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

UpToDate® LexidrugTM. Sodium ferric gluconate complex in sucrose (Ferrlecit®). [UpToDate Lexidrug Web site]. 08/29/2025. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed September 24, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Ferric carboxymaltose (Injectafer®). Prescribing information. [FDA Web site]. 01/03/2025. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed September 24, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Ferric derisomaltose (Monoferric®). Prescribing information. [FDA Web site]. 08/01/2024. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed September 24, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Ferumoxytol (Feraheme®). Prescribing information. [FDA Web site]. 06/16/2022. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed September 24, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Iron dextran (INFeD®). Prescribing information. [FDA Web site]. 08/01/2024. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed September 24, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Iron sucrose (Venofer®). Prescribing information. [FDA Web site]. 08/01/2024. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed September 24, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Sodium ferric gluconate complex in sucrose (Ferrlecit®). Prescribing information. [FDA Web site]. 03/16/2022. Available at:  https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed September 24, 2025.

Vadhan-Raj S, Strauss WE, Ford D, et al. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol. 2014;89(1):7-12.

Van Wyck DB, Roppolo M, Martinez CO, et al. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005;68(6):2846-2856.

World Health Organization (WHO). WHO guideline on use of ferritin concentrations to assess iron status in individuals and populations. 2020. Available at: https://iris.who.int/handle/10665/331505. Accessed September 24, 2025.​

Coding

CPT Procedure Code Number(s)
N/A​
ICD - 10 Procedure Code Number(s)
N/A​
ICD - 10 Diagnosis Code Number(s)
D50.0 Iron deficiency anemia secondary to blood loss (chronic)
D50.8 Other iron deficiency anemias​
D50.9 Iron deficiency anemia, unspecified
D63.0 Anemia in neoplastic disease
D63.1 Anemia in chronic kidney disease
D64.81 Anemia due to antineoplastic chemotherapy
E61.1 Iron deficiency
O99.011 Anemia complicating pregnancy, first trimester
O99.012 Anemia complicating pregnancy, second trimester
O99.013 Anemia complicating pregnancy, third trimester
O99.019 Anemia complicating pregancy, unspecified trimester
O99.02 Anemia complicating childbirth
O99.03 Anemia complicating the puerperium
​
THE FOLLOWING CODES REPRESENT MANAGEMENT OF HEART FAILURE WITH FERRIC CARBOXYMALTOSE (INJECTAFER)

​​I50.89 Other heart failure
I50.9 Heart failure, unspecified
HCPCS Level II Code Number(s)
J1437 ​Injection, ferric derisomaltose, 10 mg

J1439 Injection, ferric carboxymaltose, 1 mg

J1750 Injection, iron dextran, 50 mg

J1756 Injection, iron sucrose, 1 mg

J2916 Injection, sodium ferric gluconate complex in sucrose injection, 12.5 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)
Revenue Code Number(s)
N/A​

Coding and Billing Requirements

Policy History

Revisions From MA08.150a:
03/23/2026This version of the policy will become effective 03/23/2026.

The following policy criteria have been​ added to the policy​:

Criteria for the use of intravenous iron preparations in pediatric individuals​ 

The following ICD-10 codes have been added to the policy:

D50.0 Iron deficiency anemia secondary to blood loss (chronic)
D50.8 Other iron deficiency anemias​
​D64.81 Anemia due to antineoplastic chemotherapy
O99.011 Anemia complicating pregnancy, first trimester
O99.012 Anemia complicating pregnancy, second trimester
O99.013 Anemia complicating pregnancy, third trimester
O99.019 Anemia complicating pregancy, unspecified trimester
O99.02 Anemia complicating childbirth
O99.03 Anemia complicating the puerperium​

Revisions From MA08.150:
01/01/2025This policy will become effective 01/01/2025.

This new policy has been developed to communicate the Company's coverage criteria for intravenous (IV) iron preparations. ​

3/23/2026
3/23/2026
MA08.150
Medical Policy Bulletin
Medicare Advantage
No