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.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)|
|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)|
|D64.81||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|
For help with reimbursement, contact Daiichi Sankyo Access Central at 1-866-4-DSI-NOW (1-866-437-4669), Monday–Friday,II 9:00 AM–8:00 PM ET. Click here to learn more.
Injectafer is indicated for the treatment of iron deficiency anemia (IDA) in adults and pediatric patients 1 year of age and older who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease.1
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, 9:00 AM–8:00 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 to oral iron or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease.
Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components.
Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat- soluble vitamins or phosphate, 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.
Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.
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 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 (rarely reported event); nervous system disorders: syncope; respiratory, thoracic and mediastinal disorders: dyspnea; skin and subcutaneous tissue disorders: angioedema, erythema, pruritus, urticaria; pregnancy: fetal bradycardia.
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, injection site reactions, rash, headache, and vomiting.
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.