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Inhaled nitric oxide (INO), a treatment for neonates who have hypoxic respiratory failure, is intended to improve oxygenation, reduce mortality rates, and reduce the need for invasive extracorporeal membrane oxygenation (ECMO). It is also proposed as a treatment for premature infants, critically ill children, and adults with respiratory failure and in the postoperative management of children undergoing repair of congenital heart disease.
Hypoxic respiratory failure may result from respiratory distress syndrome (RDS), persistent pulmonary hypertension, meconium aspiration, pneumonia, or sepsis. Its treatment typically includes oxygen support, mechanical ventilation, and induction of alkalosis, neuromuscular blockade, or sedation. ECMO is an invasive technique that may be considered in neonates when other therapies fail. Inhaled nitric oxide is both a vasodilator and a mediator in many physiologic and pathologic processes.
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.”
POLICYInhaled nitric oxide may be considered medically necessary as a component of treatment of hypoxic respiratory failure in neonates born at more than 34 weeks of gestation.
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.
POLICY GUIDELINESInhaled nitric oxide appears to be of greatest benefit in individuals for whom primary or secondary pulmonary hypertension is a component of hypoxic 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:
(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:
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.
POLICY HISTORY8/27/2007: Policy added
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.
01/22/2014: Policy reviewed; no changes.
11/14/2014: Policy reviewed; description updated. Policy statement unchanged.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 8.01.37
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of the is document.