LCD/NCD Portal

NCD110.10

 

INTRAVENOUS IRON THERAPY

 

 

Effective Date of this Version

10/1/2001

 

 

Benefit Category

 

• Drugs and Biologicals

• Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

 

 

Item/Service Description

 

• Iron deficiency is a common condition in end stage renal disease (ESRD) patients undergoing hemodialysis. 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.

• Clinical management of iron deficiency involves treating patients with iron replacement products while they undergo hemodialysis.

• Body iron stores can be supplemented with either oral or intravenous (IV) iron products.

• 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.

 

 

Indications and Limitations of Coverage

 

• Effective December 1, 2000, 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 erythropoeitin therapy.

• Effective October 1, 2001, 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 erythropoeitin therapy.

 

 

Claims Processing Instructions

 

• TN 773 (Medicare Hospital Manual)

• TN 1834 (Medicare Intermediary Manual)

• TN 1708 (Medicare Carriers Manual)

• TN 763 (Medicare Hospital Manual)

• TN 1812 (Medicare Intermediary Manual)

• TN 91 (Medicare Renal Dialysis Facility Manual)

 

 

Coverage Transmittal Link

 

• http://www.cms.gov/transmittals/downloads/R139CIM.pdf

 

 

National Coverage Analyses (NCAs)

 

• This NCD has been or is currently being reviewed under the National Coverage Determination process.

• The following are existing associations with NCAs, from the National Coverage Analyses database.

• Original consideration for Ferrlecit®: Intravenous Iron Therapy (CAG-00046N) opens in new window

• Original consideration for Venofer: Intravenous Iron Therapy (CAG-00080N) opens in new window

 

 

Medicare NCD Link