CurrentUnitedHealthcarePolicy CS173.J

Inhaled Nitric Oxide Therapy

UnitedHealthcare medical policy CS173.J governing coverage of inhaled nitric oxide therapy for newborns and infants, with clinical criteria for term/near-term infants, exclusions (congenital diaphragmatic hernia, preterm <34 weeks), state-specific applicability notes, coding reference, supporting evidence, and policy history.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy

Policy CodePolicy CS173.J

Change TypeApplication, Definitions, Supporting Info updates

Effective DateNov 1, 2024

Next Review Date

Key ActionProviders must document gestational age (>=34 weeks), clinical evidence of hypoxic respiratory failure or echocardiographic evidence of PPHN, failure of conventional treatments, and absence of CDH for coverage.

POLICY UPDATE CHANGES

Application: Added language indicating the policy does not apply to the states of Idaho and Kansas; refer to state-specific policy versions.

Definitions: Added definition of 'Infancy'.

Supporting Information: Updated Clinical Evidence, FDA, and References sections to reflect current information.

1Primary covered population (term/near-term infants >=34 wks)

1Exclusion: preterm <34 wks

1Exclusion: congenital diaphragmatic hernia (CDH)

Coverage Summary

This UnitedHealthcare coverage criteria (Policy CS173.J, effective 11/01/2024, last reviewed/updated 06/01/2025) takes a mixed coverage stance on inhaled nitric oxide (iNO) therapy in newborns and infants. iNO is covered as medically necessary for term or near-term infants born at ≥34 weeks gestation with hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN) when conventional treatments have failed and congenital diaphragmatic hernia (CDH) is absent. The policy also allows clinically accepted use of iNO as bridge therapy during the acute postoperative recovery phase for pulmonary hypertension after heart or lung surgery in infants. iNO is considered not medically necessary/unproven for other newborns, including those with CDH and preterm infants born at <34 weeks, where evidence is inconsistent or suggests potential harm. Note: this policy does not apply to certain states — see state-specific policy versions where indicated.

Key thresholds and quick facts

Gestational age threshold>= 34 weeks (term or near-term infants eligible)

Oxygenation index threshold> 25 (recommendation to reduce need for ECMO)

Primary covered populationTerm/near‑term infants (>=34 weeks) with hypoxic respiratory failure or echocardiographic evidence of PPHN who have failed conventional treatments

Explicit exclusionsPreterm infants <34 weeks and newborns with congenital diaphragmatic hernia (CDH) are not covered

Billing / coding noteCPT 94799 (Unlisted pulmonary service or procedure) provided as the reporting code

Policy effective / applicability notePolicy effective Nov 1, 2024; does not apply to specified states (see state-specific versions)

Medical-Necessity Criteria

Medically Necessary / Covered Indications

iNO is proven and medically necessary when ALL of the following are met:

Gestational age: Patient is a term or near-term infant (at least 34 weeks gestation at birth).>= 34 weeks
Document gestational age.
Diagnosis of hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN).
Document clinical or echocardiographic evidence of PPHN.
Prior therapy: Failure of conventional treatments (e.g., mechanical ventilation).
Document failure of conventional treatments such as mechanical ventilation.

Applicable Codes

Reference CPT CodesCPT

94799

Unlisted pulmonary service or procedure

Provider Actions & Billing

Documentation Required

Document gestational age and diagnosis

Document gestational age (>=34 weeks) and clinical evidence of hypoxic respiratory failure or echocardiographic evidence of PPHN. Also document failure of conventional treatments (for example, mechanical ventilation) and the absence of congenital diaphragmatic hernia (CDH) to support coverage under the medically necessary criteria.

Gestational age >= 34 weeks at birth
Clinical diagnosis of hypoxic respiratory failure or echo evidence of PPHN
Failure of conventional treatments (e.g., mechanical ventilation)
No congenital diaphragmatic hernia (CDH)

Documentation Required

Document postoperative indication if used as bridge therapy

Background & Evidence Summary

Background: Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator used to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term newborns with hypoxic respiratory failure and PPHN by decreasing pulmonary vascular resistance. High-quality evidence (meta-analyses and randomized trials) supports benefit in infants born at ≥34 weeks, reducing death or need for ECMO. In preterm infants (<34 weeks) the evidence is inconsistent and does not show clear benefit and in some analyses suggests potential harms (for example, increased risk of severe intraventricular hemorrhage or other adverse outcomes). For newborns with congenital diaphragmatic hernia (CDH), systematic reviews and trials have not demonstrated improved relevant outcomes (death or need for ECMO) and raise concerns about possible harm, so routine use is not recommended.

Source	Key finding
Wang et al. 2019 (meta-analysis)	iNO reduced combined outcome of death or ECMO in infants ≥34 weeks (relative decrease ~34%).
Cochrane Barrington et al. 2017a	High-quality evidence iNO reduces incidence of combined endpoint death or ECMO in term/near-term infants without CDH; initial concentration 20 ppm effective.
Cochrane Barrington et al. 2017b	No clear benefit of iNO in preterm infants; meta-analysis suggested possible increased risk of grade 3–4 intraventricular hemorrhage.
Hayes review	Moderate-quality evidence that iNO does not decrease risk of BPD or improve survival in preterm infants; routine/prophylactic use not supported.

Definitions

InfancyThe period from birth through the first year of life.

Revision History

2025-06-01revisionLatest

Material revision: Application section updated to add Idaho and Kansas exclusions; policy does not apply to those states and refers readers to state-specific policy versions.

2024-11-01revision

Revision: Definitions section added definition of 'Infancy' and Supporting Information (Clinical Evidence, FDA, References) updated; prior policy version CS173.1 archived.

2024-11-01update

Effective date of policy set to November 1, 2024 (policy document effective date).