Medical Necessity Determination for Ferric Carboxymaltose (J1439)

The requested ferric carboxymaltose is NOT medically necessary based on the current clinical documentation.

The patient does not meet established criteria for intravenous iron therapy because:

The patient's ferritin level of 62 ng/mL is within normal range (16-154 ng/mL) and does NOT meet the threshold for iron deficiency anemia 1
For IDA without chronic kidney disease, iron deficiency requires either serum ferritin <30 ng/mL OR transferrin saturation (TSAT) <20% 2
The clinical record shows ferritin of 62 ng/mL with no TSAT value documented, failing to establish iron deficiency by either criterion
Hemoglobin (13.4 g/dL) and hematocrit (41.7%) are both within normal limits, further contradicting the diagnosis of iron deficiency anemia 1

The FDA-approved indication for ferric carboxymaltose requires documented IDA in patients ≥1 year with either intolerance to oral iron OR unsatisfactory response to oral iron 1
The diagnosis D50.9 (iron deficiency anemia, unspecified) is not supported by the laboratory values presented
The patient's normal hemoglobin and ferritin levels contraindicate the use of IV iron, as ferric carboxymaltose should not be administered when hemoglobin >15 g/dL, and efficacy has not been established in patients without true iron deficiency 2, 1

There is no evidence in the medical record of a trial of oral iron therapy, intolerance to oral iron, or unsatisfactory response to oral iron 1
The active medication list shows only folic acid 1 mg daily—no oral iron supplementation documented
FDA labeling explicitly requires either intolerance or unsatisfactory response to oral iron before IV ferric carboxymaltose is indicated 1
Guidelines recommend oral iron as first-line therapy unless contraindicated or ineffective 2

The patient has multiple complex medical conditions (psoriatic arthritis, POTS/dysautonomia, MCAS, gastroparesis, Barrett's esophagus) that may explain fatigue and weakness without requiring iron therapy [@case documentation]
The diagnosis of "iron deficiency (E61.1)" documented on page 6 is not supported by objective laboratory evidence
Before approving IV iron, other causes of the patient's symptoms should be thoroughly evaluated

Ferric carboxymaltose is contraindicated in patients with anemia not attributed to iron deficiency [@5@, 1]
Administration to a patient without documented iron deficiency risks unnecessary adverse effects including hypophosphatemia (which can be severe with repeat dosing), hypersensitivity reactions, and hypertension [@6@, 1]
The patient's complex medical history including dysautonomia and POTS may increase risk of adverse hemodynamic effects from IV iron administration

To establish medical necessity, the following must be documented:

Laboratory confirmation of iron deficiency:
- Serum ferritin <30 ng/mL, OR
- Ferritin 30-100 ng/mL with TSAT <20% [@1@, 2, @8@]
Evidence of anemia:
- Hemoglobin below normal range for age and sex [@8@, 1]
Documentation of oral iron therapy:
- Specific oral iron preparation, dose, and duration tried
- Evidence of intolerance (specific adverse effects documented), OR
- Evidence of unsatisfactory response (persistent anemia/iron deficiency after adequate trial of 4-8 weeks) [1, @10@]
If claiming heart failure indication:
- Documentation of NYHA class II/III heart failure
- LVEF ≤45%
- Ferritin <100 μg/L OR ferritin 100-299 μg/L with TSAT <20% 2, 1

DENY the request for ferric carboxymaltose (J1439) as not medically necessary. The patient requires:

Repeat iron studies including ferritin and TSAT to accurately assess iron status
If true iron deficiency is confirmed (ferritin <30 ng/mL or TSAT <20%), initiate trial of oral iron therapy first unless specific contraindications exist
Comprehensive evaluation for alternative causes of fatigue and weakness given normal hemoglobin and ferritin levels
Re-submission with complete documentation if iron deficiency is confirmed and oral iron fails or is contraindicated [@8@, @10