Medical Policy
Effective Date:10/03/2012 Title:Inhaled Nitric Oxide (INO)
Revision Date:12/01/2016 Document:BI374:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    QualChoice considers inhaled nitric oxide (INO) therapy medically necessary to treat hypoxic respiratory failure in term and near term (born at 34 or more weeks of gestation) neonates without congenital diaphragmatic hernia.

2)    QualChoice considers INO medically necessary as a method of assessing pulmonary vasoreactivity in members with pulmonary hypertension.

3)    Any other use of INO, including but not limited to acute respiratory distress syndrome (ARDS), use in preterm (born before 34 weeks) neonates, or use in neonates with diaphragmatic hernia, is considered experimental, investigational, or unproven.
Medical Statement

1)    Inhaled nitric oxide is considered medically necessary for the treatment of hypoxic respiratory failure in term or near-term (born at 34 weeks or greater gestational age) neonates without congenital diaphragmatic hernia.  Use for more than 14 days is subject to medical necessity review.

2)    INO is also considered medically necessary as a method of assessing pulmonary vasoreactivity in patients with pulmonary hypertension undergoing diagnostic catheterization.

3)    INO is not considered medically necessary for any other use, including the following:

a)  Acute bronchiolitis (J21.0 – J21.9)

b)  Adult Respiratory Distress Syndrome (J80) or acute lung injury (S27.301A –

     S27.301D, S27.302A – S27.302D, S27.309A – S27.309D)

c)  Post-operative management of pulmonary hypertension in infants and

     children with congenital heart disease (Q24.2 – Q24.9)

d)  Prevention of Broncho-pulmonary dysplasia in neonates

e) Treatment of term or near term neonates with diaphragmatic hernia (Q79.0 – Q79.1)

f)  Treatment of premature (born at less than 34 weeks) neonates (P07.20-P07.36) with

     or without pulmonary hypertension

g)  Treatment of vaso-occlusive crises or acute chest syndrome in persons with sickle

     cell disease (D57.00 – D57.01, D57.211 – D57.219, D57.411 – D57.419, D57.811 –

     D57.819)
Limits
Intentially left empty
Reference

1)    NIH Consensus Development Statement on Inhaled Nitric Oxide Therapy for Premature Infants. NIH Consensus and State-of-the-Science Statements 2010; 27(5)

2)    American Academy of Pediatrics.  Committee on Fetus and Newborn.  Use of inhaled nitric oxide.  Pediatrics 2000; 106(2 Pt 1):344-345.

3)    Allen MC, et al.  Inhaled nitric oxide in infants.  AHRQ Evidence Report/Technology Assessment Number 195, 2010

4)    Mercier JC et al.  Inhaled nitric oxide for prevention of Broncho pulmonary dysplasia in premature babies (EUNO): a randomized controlled trial.  Lancet 2010; 376:346-54.

5)    Shah DM and Kluckow M.  Early functional echocardiogram and inhaled nitric oxide:  Usefulness in managing neonates born following extreme preterm premature rupture of membranes. J Pediatric Child Health 2011 Jun; 47(6);340-5

6)    Kinsella et al. Inhaled nitric oxide in premature neonates with severe hypoxaemic respiratory failure: a randomized controlled trial.  Lancet 1999; 354:1061-5

7)    Afshari A, Brok J, Møller AM, Wetterslev J. Inhaled nitric oxide for acute respiratory distress syndrome (ARDS) and acute lung injury in children and adults. Cochrane Database Syst Rev. 2010;(7):CD002787

8)    Van Meurs et al.  Inhaled nitric oxide for premature infants with severe respiratory failure. NEJM 2005; 353(1):13-22

9)    Schreiber MD et al.  Inhaled nitric oxide in premature infants with the respiratory distress syndrome.  NEJM 2003; 349:2099-107
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.