This document addresses laboratory testing for iron levels. Iron studies can include serum testing of ferritin, iron, and either iron binding capacity or transferrin. These tests are used in the differential diagnosis of iron deficiency, anemia, and iron overload.

Clinical Indications

Medically Necessary:

Serum iron testing is considered medically necessary for any of the following indications:

1. Evaluation of suspected iron deficiency in individuals who meet any of the following criteria:
   1. Abnormal blood counts consistent with iron deficiency including, but not limited to, the following:
      1. decreased mean corpuscular volume (MCV); or
      2. decreased hemoglobin/hematocrit when the MCV is low or normal; or
      3. increased red cell distribution width (RDW) and low or normal MCV; or
   2. Evidence of acute or chronic blood loss including, but not limited to, the following:
      1. gastrointestinal blood loss; or
      2. hematuria; or
      3. menorrhagia; or
   3. Anemia associated with abnormal appetite, malnutrition, or malabsorption; or
   4. Malignancy, chronic inflammation or infection associated with iron deficiency; or
   5. A lack of response to iron replacement therapy; or
   6. Symptoms or clinical findings associated with iron deficiency; or
2. Evaluation of suspected iron overload in individuals who meet any of the following criteria:
   1. Diagnosis of a condition associated with iron overload; or
   2. Symptoms or clinical findings associated with iron overload; or
3. Evaluation of toxic effects of iron and other metals after exposure or for metabolic causes; or
4. Evaluation of iron status following treatment for other nutritional deficiency anemias such as vitamin B12 or folate deficiency; or
5. Monitoring treatment response following iron replacement therapy or treatment with erythropoiesis-stimulating agents.

Not Medically Necessary:

Serum iron testing is considered not medically necessary when the above criteria are not met, and for all other indications, including but not limited to the following:

1. Screening of individuals in the absence of signs, symptoms, or medical history suggestive of iron dysregulation; or
2. During acute inflammation or infection where the results will not impact or direct treatment or disease management; or
3. After a normal serum ferritin level has been documented, monitoring iron status in the absence of signs or symptoms of iron imbalance.

Concurrent assessment of transferrin and TIBC is considered not medically necessary for any indication.