Inhaled nitric oxide (INO) is a natural vasodilator and has been studied for the treatment of a variety of types of respiratory failure. Most commonly, it is used as an initial treatment for neonates with hypoxic respiratory failure to improve oxygenation 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, as well as in the postoperative management of children undergoing repair of congenital heart disease and individuals after lung transplantation to prevent or reduce reperfusion injury.
Inhaled 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.
Inhaled nitric oxide is considered experimental/investigational, and therefore non-covered, because the safety and/or effectiveness cannot be established by available published peer-reviewed literature, including, but not limited to ANY ONE of the following indications:
Inhaled nitric oxide appears to be of greatest benefit to individuals for whom primary or secondary pulmonary hypertension is a component of hypoxic respiratory failure.
The benefit of INO 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 (OI) of at least 25 on 2 measurements made at least 15 minutes apart.
(The OI is calculated as the mean airway pressure times the fraction of inspired oxygen divided by the postductal partial pressure of arterial oxygen times 100. An OI of 25 is associated with a 50% risk of requiring ECMO or dying. An OI of 40 or more is often used as a criterion to initiate ECMO therapy.)
Clinical input from specialty societies and academic medical centers indicates that:
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
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You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.