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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, adults with respiratory failure, in the postoperative management of children undergoing repair of congenital heart disease, and in lung transplantation to prevent or reduce reperfusion injury.
Inhaled nitric oxide (INO) has been proposed to reduce hypoxic respiratory failure in neonates and for several other applications.
Hypoxic respiratory failure may result from respiratory distress syndrome, persistent pulmonary hypertension, meconium aspiration, pneumonia, or sepsis. Its treatment typically includes oxygen support, mechanical ventilation, and induction of alkalosis, neuromuscular blockade, or sedation. Extracorporeal membrane oxygenation 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. Inhaled nitric oxide has also been proposed for use in preterm infants less than 34 weeks of gestation.
Another potential application of inhaled nitric oxide is to improve oxygenation in patients with acute hypoxemic respiratory failure, including acute respiratory distress syndrome and acute lung injury. These conditions are associated with inflammation of the alveolar-capillary membrane, which leads to hypoxemia and pulmonary hypertension.
In addition, there are several potential uses in surgery. One is the proposed use of inhaled nitric oxide to manage 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. Another potential surgical application is use of inhaled nitric oxide in lung transplantation to prevent or reduce reperfusion injury.
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.
In 1999, INOmax™ (Ikaria, Clinton, NJ) was cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process 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.” In 2015, Mallinckrodt (Dublin, Ireland) acquired Ikaria.
In 2014, Advanced Inhalation Therapies received orphan drug designation for its proprietary formulation of nitric oxide as an adjunctive treatment of cystic fibrosis.
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:
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Inhaled 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:
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
08/26/2015: Code Reference section updated for ICD-10.
05/26/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
07/20/2016: Policy description updated regarding potential surgical applications using inhaled nitric oxide. Investigational policy statement reformatted to list criteria. Added postoperative use in adults and children with congeital heart disease and in lung transplantation, during and/or after graft reperfusion to the investigational policy statement.
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.