This document addresses the use of inhaled nitric oxide (INO or iNO). INO has been considered a technique to improve oxygenation in critically ill individuals with hypoxic respiratory failure, both to reduce mortality and, in neonates, to reduce the need for extracorporeal membrane oxygenation (ECMO). Hypoxic respiratory failure may result from respiratory distress syndrome (RDS), persistent primary pulmonary hypertension, pulmonary hypoplasia, congenital diaphragmatic hernia (CDH), meconium aspiration, pneumonia, or sepsis.

Clinical Indications

Medically Necessary:

1. Inhaled nitric oxide is considered medically necessary as a component of the treatment of hypoxic respiratory failure (see definition) in neonates when the following criteria are met:
   1. The neonate was born at 34 or more weeks of gestation; and
   2. Conventional therapies have failed or are expected to fail, for example, administration of high concentrations of oxygen, hyperventilation, high frequency ventilation, the induction of alkalosis, neuromuscular blockade and sedation; and
   3. Neonate does not have a congenital diaphragmatic hernia.
2. Inhaled nitric oxide is considered medically necessary as a method of assessing (not treating) pulmonary vasoreactivity in individuals with pulmonary hypertension.

Not Medically Necessary:

Inhaled nitric oxide is considered not medically necessary when the criteria above are not met and for all other indications, including, but not limited to:

• Treatment of hypoxic respiratory failure in premature neonates born at less than 34 weeks gestational;
• Treatment of acute respiratory distress syndrome in adults;
• Pre-operative, operative, and post-operative management of congenital heart disease.