Diagnosis: Respiratory Syncytial Virus (RSV) prophylaxis
Treatment: Synagis 100 milligrams/milliliter (mg/ml) intramuscular (IM)

The insurer denied coverage for Synagis 100 milligrams/milliliter (mg/ml) intramuscular (IM).
The denial is upheld.

This is an infant with a history of tricuspid atresia, transposition of the great arteries (TGA), and pulmonary stenosis. He presented to the Pediatrician's office with complaints of upper respiratory congestion and coughing. The patient was noted to have an acute respiratory infection. There were minimal problems. The treating physician recommended Synagis to prevent RSV.

Guidelines for Evidenced-Based Synagis Prophylaxis:

Infants younger than 12 months at start of season with a diagnosis of:

1. Prematurity - born before 29 weeks 0 days gestation.

Infants in their first year of life with a diagnosis of:

1. Chronic Lung Disease (CLD) of prematurity (defined as birth at less than 32 weeks 0 days gestation and requiring greater than 21 percent oxygen for at least 28 days after birth).
2. Hemodynamically significant acyanotic heart disease (CHD), receiving medication to control congestive heart failure, and will require cardiac surgical procedures.
3. Moderate to severe pulmonary hypertension.
4. Neuromuscular disease or pulmonary abnormality that impairs the ability to clear secretions from the upper airways because of ineffective cough.

Note: Infants with cyanotic heart disease may receive prophylaxis with cardiologist recommendation.

Infants less than 24 months of age with a diagnosis of:

1. Profound immunocompromise during RSV season.
2. CLD of prematurity (see above definition) and continue to require medical support, supplemental oxygen, chronic corticosteroid or diuretic therapy during the six-month period before start of second RSV season.
3. Cardiac transplantation during RSV season.

Synagis is effective as shown in CHD and also beneficial and improves outcomes in neuromuscular disease or congenital anomaly that impairs ability to clear respiratory secretions from the upper airway. There is no evidence that shows beneficial effects nor toxic effects/adverse effects in children above 24 months. Hence denying the request and could not fulfill the medical necessity.

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Synagis 100 milligrams/milliliter (mg/ml) intramuscular (IM) is upheld. Medical Necessity is not substantiated.