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INOmax, a commercially available inhaled nitric oxide product, is FDA-approved for use in term and near-term neonates with hypoxic respiratory failure along with respiratory support and other appropriate treatments. Inhaled nitric oxide has also been proposed for use in preterm infants <34 weeks’ gestation. Another potential application of inhaled nitric oxide is to improve oxygenation in patients with acute hypoxemic respiratory failure (AHRF), including acute respiratory distress syndrome (ARDS) and acute lung injury. These conditions are associated with inflammation of the alveolar-capillary membrane which leads to hypoxemia and pulmonary hypertension. In addition, inhaled nitric oxide is proposed for management of pulmonary hypertension after cardiac surgery in infants and children with congenital heart disease. In congenital heart disease patients, increased pulmonary blood flow can cause pulmonary hypertension. Cardiac surgery can restore the pulmonary vasculature to normal but there is the potential for complications including post-operative pulmonary hypertension which can prevent weaning from ventilation and is associated with substantial morbidity and mortality.

INOmax™ received U.S. Food and Drug Administration (FDA) approval in 1999 for the following indication:

“INOmax, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.”

Other indications for inhaled nitric oxide are investigational, including, but not limited to, its use in premature neonates born at less than or equal to 34 weeks of gestation, adults and children with acute hypoxemic respiratory failure.  

The benefit of inhaled nitric oxide appears limited in term or near-term infants whose hypoxic respiratory failure is due to diaphragmatic hernia.

The following criterion for hypoxic respiratory failure has been reported:

• An oxygenation index of at least 25 on 2 measurements made at least 15 minutes apart.

(The oxygenation index [OI] is calculated as the mean airway pressure times the fraction of inspired oxygen divided by the partial pressure of arterial oxygen times 100. An OI of 25 is associated with a 50% risk of requiring extracorporeal membrane oxygenation [ECMO] or dying. An OI of 40 is often used as a criterion to initiate ECMO therapy.)

Clinical input from academic medical centers and specialty societies obtained in 2012 indicated that:

• Prolonged use of INO [inhaled NO] beyond 1-2 weeks has not been shown to improve outcomes. Use of INO beyond 2 weeks of treatment is therefore not recommended.
• If ECMO is initiated in near-term neonates, inhaled NO should be discontinued as there is no benefit to combined treatment.

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

11/15/2007: Policy approved by MPAC

9/11/2008: Policy reviewed, no changes

07/15/2010:  Policy reviewed; no changes.

09/23/2011:  Policy description updated. The medically necessary statement was changed from “34 or more weeks of gestation” to “more than 34 weeks of gestation” for consistency with FDA approval of the technology. The investigational statement on premature neonates was changed from “less than 34 weeks” to “less than or equal to 34 weeks”.  Added the use of this technology in adults and children with acute hypoxemic respiratory failure and postoperative management of pulmonary hypertension in children with congenital heart disease to the investigational policy statement.  The title was changed to “Inhaled Nitric Oxide” to reflect the expanded scope of the policy. Deleted ICD-9 code 765.27 from the Covered Codes table.

01/09/2013:  Deleted postoperative management of pulmonary hypertension in children with congenital heart disease from the investigational policy statement. Added criteria to the policy guidelines regarding hypoxic respiratory failure and benefits of inhaled nitric oxide.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes