Proper billing and coding can help ensure appropriate patients receive timely treatment. The following codes may be helpful to facilitate Injectafer reimbursement. The completion and submission of coverage-related documentation are the responsibility of the patient and healthcare provider.
|Product Package Code|
|NDC||00517-0650-01||Injectafer 750 mg iron/15 mL single-dose vial (individually boxed)|
|NDC||0517-0602-01||Injectafer 100 mg iron/2 mL single-dose vial (individually boxed)|
|Product-Specific Billing Code|
|HCPCS†||J1439||Injection, ferric carboxymaltose 1 mg|
|Drug Administration Codes|
|CPT®*||96374||Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug|
|or 96365||Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour|
*CPT® codes, 2019 American Medical Association (AMA). All rights reserved. CPT is a trademark of the AMA. No fee schedules, basic units, relative values, or related listings are included in the CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.
†Use this unique J code for Injectafer when billing for claims to insurance.Abbreviations: CPT, Current Procedural Terminology; FARS/DFARS, Federal Acquisition Regulation/Defense Federal Acquisition Regulation Supplement; HCPCS, Healthcare Common Procedure Coding System; NDC, National Drug Code.
Injectafer claims forms require an appropriate ICD-10-CM code. The following table displays possible ICD-10-CM codes related to IDA.†
|D50.0||Iron deficiency anemia secondary to blood loss (chronic)|
|E61.1||Iron Deficiency (excludes iron deficiency anemia (D50.0))|
|D50.8||Other iron deficiency anemias|
|D50.9||Iron deficiency anemia, unspecified|
|D63.0||Anemia in neoplastic disease CODE NEOPLASM FIRST (Confirm iron deficiency)|
|D63.1||Anemia in chronic kidney disease CODE CKD STAGE FIRST (Confirm iron deficiency)|
|D63.8||Anemia in other chronic diseases classified elsewhere CODE UNDERLYING DISEASE FIRST (Confirm iron deficiency)|
|D63.81||Antineoplastic chemotherapy-induced anemia (Confirm iron deficiency)|
Other codes may be appropriate.
Coding for Injectafer is dependent on the insurer and the care setting in which the drug will be administered. THESE TABLES ARE PROVIDED FOR INFORMATIONAL PURPOSES ONLY, AND YOU HAVE THE RESPONSIBILITY TO ENSURE THAT CLAIMS AND CODES SUBMITTED ARE ACCURATE, COMPLETE, and APPLICABLE. Healthcare providers need to make coding decisions based on the diagnosis and treatment of each patient and the specific insurer. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes.
The following table displays possible secondary ICD-10-CM codes that may be appropriate for patients prescribed Injectafer.§
|K50.0-K50.919||Crohn‘s disease (regional enteritis)|
|K90.4||Malabsorption due to intolerance not elsewhere classified|
|K90.9||Intestinal malabsorption, unspecified|
|N18.1||Chronic kidney disease, stage 1|
|N18.2||Chronic kidney disease, stage 2|
|N18.30||Chronic kidney disease, stage 3 unspecified|
|N18.31||Chronic kidney disease, stage 3a|
|N18.32||Chronic kidney disease, stage 3b|
|N18.4||Chronic kidney disease, stage 4|
|N18.5||Chronic kidney disease, stage 5|
|N18.6||End-stage renal disease|
|N18.9||Chronic kidney disease, unspecified|
|N92.0||Excessive and frequent menstruation with regular cycle|
|N92.5||Other specified irregular menstruation|
|N92.6||Irregular menstruation, unspecified|
|T45.4X5A||Adverse effect of iron and its compounds, initial encounter|
|T50.905A||Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter|
The following table displays possible secondary ICD-10-CM codes that may be appropriate for patients prescribed Injectafer.†
|I09.81||Rheumatic Heart Failure|
|I11.0||Hypertensive Heart Disease with Heart Failure|
|I50.1||Left Ventricular Failure, Unspecified|
|I50.2||Systolic (Congestive) Heart Failure|
|I50.20||Unspecified Systolic (Congestive) Heart Failure|
|I50.21||Acute Systolic (Congestive) Heart Failure|
|I50.22||Chronic Systolic (Congestive) Heart Failure|
|I50.23||Acute on Chronic Systolic (Congestive) Heart Failure|
|I50.3||Diastolic (Congestive) Heart Failure|
|I50.30||Unspecified Diastolic (Congestive) Heart Failure|
|I50.31||Acute Diastolic (Congestive) Heart Failure|
|I50.32||Chronic Diastolic (Congestive) Heart Failure|
|I50.33||Acute on Chronic Diastolic (Congestive) Heart Failure|
|I50.4||Combined Systolic and Diastolic (Congestive) Heart Failure|
|I50.40||Unspecified Combined Systolic and Diastolic (Congestive) Heart Failure|
|I50.41||Acute Combined Systolic and Diastolic (Congestive) Heart Failure|
|I50.42||Chronic Combined Systolic and Diastolic Heart Failure|
|I50.43||Acute on Chronic Combined Systolic and Diastolic Heart Failure|
|I50.8||Other Heart Failure|
|I50.81||Right Heart Failure|
|I50.810||Right Heart Failure, Unspecified|
|I50.811||Acute Right Heart Failure|
|I50.812||Chronic Right Heart Failure|
|I50.813||Acute on Chronic Right Heart Failure|
|I50.814||Right Heart Failure Due to Left Heart Failure|
|I50.82||Biventricular Heart Failure|
|I50.83||High Output Heart Failure|
|I50.84||End Stage Heart Failure|
|I50.89||Other Heart Failure|
|I50.9||Heart Failure, Unspecified|
For help with reimbursement, contact Daiichi Sankyo Access Central at 1-866-4-DSI-NOW (1-866-437-4669), Monday–Friday,II 8:00 AM–6:00 PM ET. Click here to learn more.
Injectafer is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease. Injectafer is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
Dilute up to 750 mg of Injectafer in up to 250 mL (but not more) of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL. Administer over at least 15 minutes.1
At concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.1
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Injectafer is intended for single-use only. Any unused drug remaining after injection must be discarded.1
For eligible patients, Injectafer is covered under the medical benefit of most health insurance plans.For information on reimbursement and patient support options, call Daiichi Sankyo Access Central at 1-866-4-DSI-NOW, Monday–Friday, 8:00 AM–6:00 PM ET or visit dsiaccesscentral.com/hcp/injectafer.
Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. Injectafer is also indicated for iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.
Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.
Symptomatic hypophosphatemia with serious outcomes including osteomalacia and fractures requiring clinical intervention has been reported in patients treated with Injectafer in the post-marketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. However, symptomatic hypophosphatemia has been reported after one dose. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency, and malnutrition. In most cases, hypophosphatemia resolved within three months.
Correct pre-existing hypophosphatemia prior to initiating therapy with Injectafer. Monitor serum phosphate levels in patients at risk for chronic low serum phosphate. Check serum phosphate levels prior to a repeat course of treatment in patients at risk for low serum phosphate and in any patient who receives a second course of therapy within three months. Treat hypophosphatemia as medically indicated.
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life- threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.
In clinical studies, hypertension was reported in 4% (67/1775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer administration.
In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer.
In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to Injectafer, 15 mg/kg of body weight, up to a maximum single dose of 750 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose of 1500 mg of iron. Adverse reactions reported by >2% of Injectafer-treated patients were nausea (7.2%); hypertension (4%); flushing (4%); injection site reactions (3%); erythema (3%); hypophosphatemia (2.1%); and dizziness (2.1%).
The safety of Injectafer in pediatric patients was evaluated in Study 3. Study 3 was a randomized, active- controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15 mg/kg to a maximum single dose of 750 mg (whichever was smaller) on Days 0 and 7 for a maximum total dose of 1500 mg; 38 patients evaluable for safety in the control arm received an age- dependent formulation of oral ferrous sulfate for 28 days. The median age of patients who received Injectafer was 14.5 years (range, 1-17); 83% were female; 88% White and 13% Black. The most common adverse reactions (≥4%) were hypophosphatemia (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%).
The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780), CONFIRM-HF (NCT01453608) and AFFIRM-AHF (NCT02937454) in which 1016 patients received Injectafer versus 857 received placebo. The overall safety profile of Injectafer was consistent across the studied indications.
The following adverse reactions have been identified during post approval use of Injectafer. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported from the post-marketing spontaneous reports with Injectafer: cardiac disorders: tachycardia; general disorders and administration site conditions: chest discomfort, chills, pyrexia; metabolism and nutrition disorders: hypophosphatemia; musculoskeletal and connective tissue disorders: arthralgia, back pain, hypophosphatemic osteomalacia; nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.
Untreated IDA in pregnancy is associated with adverse maternal outcomes such as postpartum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.
Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Injectafer) which may cause fetal bradycardia, especially during the second and third trimester.
You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.