HCPCS Code Description
J1756 Injection, Iron Sucrose, 1 mg (Venofer®)
J2916 Injection, Sodium Ferric Gluconate Complex in Sucrose Injection, 12.5 mg (Ferrlecit®)
Description
Sodium ferric gluconate complex in sucrose (Ferrlecit®) injection is an iron replacement product.
FDA Approved Indication(s)
Ferrlecit is indicated for the treatment of iron deficiency anemia (IDA) in adult patients and in pediatric patients with chronic kidney disease (CKD) receiving hemodialysis who are receiving supplemental epoetin therapy.
Overview
Iron is a critical structural component of hemoglobin, a key protein found in normal red blood cells (RBCs) which transport oxygen. Without this important building block, anemic patients experience difficulty in restoring adequate, healthy RBCs that improve hematocrit levels. Iron deficiency is a common condition in end stage renal disease (ESRD) patients undergoing hemodialysis. Clinical management of iron deficiency involves treating patients with iron replacement products while they undergo hemodialysis. The available evidence suggests that the mode of intravenous administration is perhaps the most effective treatment for iron deficiency in hemodialysis patients. Unlike oral iron products, which must be absorbed through the GI tract, IV iron products are infused directly into the bloodstream in a form that is readily available to the bone marrow for RBC synthesis, resulting in an earlier correction of iron deficiency and anemia.
Coverage also includes the medically necessary and reasonable use of parenteral iron preparations in non-dialysis related clinical conditions.
Guidelines
Medicare covers Sodium Ferric Gluconate Complex in Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.
Medicare also covers Iron Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.
Coverage also includes for parenteral iron in iron deficiency anemia:
• For patients with iron deficiency anemia who do not respond to oral iron supplementation due to malabsorption disorders or patients who have documented intolerance to oral iron supplementation.
• For anemia related to chronic kidney disease.
• Initial treatment of absolute iron deficiency in patients receiving myelosuppressive chemotherapy who have asymptomatic anemia and risk factors for the development of symptomatic anemia requiring transfusion.
For the pregnant beneficiary when iron stores are depleted such that the mother and/or the fetus are at risk of adverse outcomes and oral iron replenishment is either not tolerated or the anemia is of such severity as to require more immediate replenishment. Additionally, use in the peripartum period may be indicated when intra/post-partum hemorrhage is severe and by administering parenteral iron a transfusion may be avoided. This indication does not replace the strong consideration for transfusions when the hemorrhage is potentially life threatening.
PURPOSE
The Medicare Advantage Policy Guideline documents are generally used to support UnitedHealthcare Medicare Advantage claims processing activities and facilitate providers’ submission of accurate claims for the specified services.
The document can be used as a guide to help determine applicable:
• Medicare coding or billing requirements, and/or
• Medical necessity coverage guidelines; including documentation requirements.
UnitedHealthcare follows Medicare guidelines such as LCDs, NCDs, and other Medicare manuals for the purposes of determining coverage. It is expected providers retain or have access to appropriate documentation when requested to support coverage. Please utilize the links in the References section below to view the Medicare source materials used to develop this resource document. This document is not a replacement for the Medicare source materials that outline Medicare coverage requirements. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will apply.
Policy
*Pleasesee amendment forPennsylvaniaMedicaidattheend ofthis CPB.
I. Aetna considers intravenous iron therapy medically necessary for any of the following indications:
A. For members needing iron supplementation who are unable to tolerate compounds given orally; or
B. For members who are losing iron (blood) at a rate too rapid for oral intake to compensate for the loss; or
C. For members with a disorder of the gastrointestinal tract, such as inflammatory bowel disease (ulcerative colitis and Crohn’s disease), in which symptoms may be aggravated by oral iron therapy; or
D. For members who are unable to maintain iron balance on treatment with hemodialysis (Note: Venofer, an iron sucrose injection, and Ferrlecit, a sodium ferric gluconate complex in sucrose injection, are indicated for the treatment of iron deficiency* anema in members undergoing chronic hemodialysis who are receiving supplemental erythropoietin/epoetin therapy; or
E. For members with iron deficiency* anemia associated with peritoneal dialysis and non-dialysis-dependent (NDD) chronic kidney disease (Note: Venofer [iron sucrose] and Feraheme [ferumoxytol] are indicated for such use, not Ferrlecit ([sodium ferric gluconate]); or
F. For members who are donating large amounts of blood for autologous programs; or
G. For members who repeatedly fail to heed instructions for oral iron supplementation or are incapable of accepting or following them; or
H. For members with chemotherapy-induced anemia; or
I. For members with heart failure and iron deficiency*, with or without anemia; or
J. For members with iron deficiency* anemia due to heavy uterine bleeding; or
K. For members with iron deficiency* following gastric bypass surgery and/or subtotal gastric resection and who exhibited decreased absorption of oral iron.
Dosing of Parentaral Iron Preparations:
Iron Dextran is available as Dexferrum in 50 mg and 100 mg Single-Dose Vials and Infed in 100 mg Single-Dose Vials. Iron dextran preparations contain 50 mg of elemental iron/ml, and are approved for iron deficiency anemia not amenable to oral iron therapy. High molecular weight (HMW) iron dextran preparations (Dexferrum) are now rarely used because they are associated with a considerably higher incidence of adverse events than are the low molecular weight (LMW) preparations (INFeD).
LMW preparations have a maximum daily dose 100 mg of elemental iron (2 ml). The recommended dosing in chronic kidney disease is elemental iron 50 to 100 mg once-weekly. There is no evidence that doses of LMW iron dextran larger than 1,000 mg are clinically useful. Once transferrin saturation greater than or equal to 20 % or serum ferritin greater than or equal to 100 ng/ml (224.7 pmol/L), IV iron therapy should be continued at lowest dose needed to maintain target hematocrit/hemoglobin levels and iron stores.
Sodium Ferric Gluconate Complex is available as Ferrlecit in 62.5 mg Single-Dose Ampules/Vials and Nulecit in 62.5 mg Single-Dose Vials. Ferric gluconate complex contains 12.5 mg/ml elemental iron. Ferrlecit (sodium ferric gluconate complex in sucrose injection) is approved for the treatment of iron defiency anemia in adult patients and pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Nulecit (sodium ferric gluconate complex in sucrose injection) is approved for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy. Ferric gluconate is approved for a maximum single dose of 125 mg, although published evidence suggests that a dose of 250 mg is well- tolerated. The adult dose 125 mg IV at or during dialysis session, and most patients require cumulative dose greater than or equal to 1,000 mg over 8 sessions. Once transferrin saturation greater than or equal to 20 % and serum ferritin level greater than or equal to 100 ng/ml achieved, ferric gluconate should be continued at the lowest dose needed to maintain hemoglobulin/hematocrit levels (for example, 25 to 100 mg elemental iron weekly for 10 weeks).
Anemia in Pregnancy & Parenteral Iron Therapy
Abstract
Anemia is common in pregnancy and iron deficiency is the most common cause. Oral iron is the standard therapy, but there is a problem of adherence due the gastrointestinal side effects. Intravenous iron therapy has more advantages, therefore, intravenous iron therapy is the best treatment for pregnant women during the third trimester. We reviewed the statistics of deliveries of the fiscal year 2012, the cases of anemia in pregnancy as in patients provided by Record Room from the calendar year 2012 and the patient cases that used sodium ferric gluconate complex in sucrose injection (FERRLECIT) from the Obstetrics/Gynecology Ward from the fiscal year 2012 provided by the Department of Pharmacy of the Ashford Presbyterian Community Hospital (APCH). A review of the records of pregnant women receiving iron dextran injection (INFeD) intravenously in our ambulatory infusion center was also performed. Our data confirmed that either presentations elevated the hemoglobin and they were well tolerable. Iron sucrose is the preferred and it has demonstrated a high success rate.
I recommend considering this alternative earlier at the third trimester and establishing guidelines using parenteral iron and erythropoietin in combination in refractory cases.
Keywords: Anemia; Pregnancy; Parenteral; Iron
Sodium Ferric Gluconate Complex in Sucrose (Ferrlecit) HCPCS code J2916: Billing Guidelines
Effective with the date of service of April 30, 2018, the North Carolina Medicaid and Health Choice (NCHC) programs will be terminating Clinical Policy 1B-3, Intravenous Iron Therapy, within the Physician Drug Program (PDP). Requirements, indications, and all other information of the policy are indicated below. From the perspective of the providers, all things associated with the process of submitting claims regarding the IV Iron agents will remain unchanged.
See prescribing information for details.
Below is information regarding Ferrlecit.
Medicaid and NCHC cover sodium ferric gluconate complex in sucrose for beneficiaries aged 6 years and older for the following FDA approved indications:
a. Iron deficiency anemia in beneficiaries undergoing chronic hemodialysis (HDD-CKD) who are receiving epoetin therapy
Medicaid and NCHC covers sodium ferric gluconate complex in sucrose for beneficiaries aged 6 years and older for the following off-label indications:
a. Iron deficiency anemia in beneficiaries with chronic kidney disease who are on peritoneal dialysis (pddckd)
b. Iron deficiency anemia in beneficiaries who are non-dialysis dependent with chronic kidney disease (nddckd)
c. Iron deficiency anemia of excessive uterine blood loss or pregnancy
d. Iron deficiency anemia in beneficiaries with cancer or who have chemotherapy- associated anemia
e. Iron deficiency anemia with comorbid heart failure
f. Iron repletion for autologous blood transfusion;
g. Gastrointestinal (gi) blood loss with iron deficiency (such as gastric bypass surgery, celiac disease, inflammatory bowel disease)
h. Disorders of iron metabolism
i. Iron deficiency where oral treatment is ineffective or infeasible
j. Iron deficiency due to intravascular hemolysis (such as paroxysmal nocturnal hemoglobinuria, valvular heart disease and malfunctioning prosthetic valves), and
k. Iron deficiency due to achlorhydria (including pernicious anemia or medication induced).
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