CurrentUnitedHealthcarePolicy CS173.L

Inhaled Nitric Oxide Therapy

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Coverage of inhaled nitric oxide therapy, primarily for newborns with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn, including selected postoperative use in infants.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy

Policy CodePolicy CS173.L

Change TypeAdministrative and supporting information update

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionDocument mechanical ventilation status, gestational maturity, and objective oxygenation data supporting PPHN treatment.

SourceLink

POLICY UPDATE CHANGES

Supporting Information was updated in the Clinical Evidence and References sections, and the previous policy version was archived.

≥34 weeksMinimum gestational age for standard coverage

20 ppmInitial iNO concentration

OI >25Oxygenation index threshold

<34 weeksGestational age below which iNO is unproven

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CurrentUnitedHealthcarePolicy CS173.L

Inhaled Nitric Oxide Therapy

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Coverage of inhaled nitric oxide therapy, primarily for newborns with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn, including selected postoperative use in infants.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy

Policy CodePolicy CS173.L

Change TypeAdministrative and supporting information update

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionDocument mechanical ventilation status, gestational maturity, and objective oxygenation data supporting PPHN treatment.

SourceLink

POLICY UPDATE CHANGES

Supporting Information was updated in the Clinical Evidence and References sections, and the previous policy version was archived.

≥34 weeksMinimum gestational age for standard coverage

20 ppmInitial iNO concentration

OI >25Oxygenation index threshold

<34 weeksGestational age below which iNO is unproven

Medical Necessity and Coverage Criteria

Initial therapy for term or near-term infants

Covered as proven and medically necessary when all criteria are met:

Initial medically necessary therapy

Population: Term or near-term infantAt least 34 weeks' gestation at birth
Indication: Hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn
Required conditions: Absence of congenital diaphragmatic hernia and failure of conventional treatments
Conventional treatments include mechanical ventilation.

Postoperative bridge therapy

Covered as a clinically accepted bridge therapy during the acute recovery phase:

Patient and condition: Infant with pulmonary hypertension
Surgical context: Pulmonary hypertension associated with heart or lung surgery
Timing: Use as bridge therapy during acute recoveryAcute recovery phase

Other newborn populations

iNO is unproven and not medically necessary for the following newborn populations:

Unproven newborn indications

Congenital diaphragmatic hernia: Newborn with congenital diaphragmatic hernia
Preterm birth: Preterm newborn born at less than 34 weeks' gestation<34 weeks at birth
Other newborns: Any other newborn not meeting the covered term or near-term criteria

Treatment outside infancy

Treatment is experimental or investigational because there are no FDA-approved indications identified by the policy:

Non-infant use: The individual is outside the infancy age group.Beyond the first year of life

Infancy is the period from birth through the first year of life.

Guideline-supported PPHN indication

Under the EPPVDN guideline-supported indication, iNO is indicated when all of the following are met:

Mechanically ventilated term or near-term newborn with PPHN

Objective oxygenation severity
- PaO2 criterion: PaO2 is less than 100 mm Hg while receiving 100% oxygen.PaO2 <100 mm Hg on 100% oxygen
- Oxygenation index criterion: The oxygenation index exceeds 25.OI >25

Postoperative pulmonary hypertension crisis

In addition to conventional postoperative care:

Postoperative pulmonary hypertension crisis or right-heart failure: iNO and/or inhaled prostacyclin may be used as initial therapy for pulmonary hypertension crises and failure of the right side of the heart.

AHA/ATS Class I recommendation; level of evidence B.

Newborns with congenital diaphragmatic hernia (CDH) are excluded from the covered indication for inhaled nitric oxide (iNO). iNO is therefore unproven and not medically necessary for this population.

Preterm newborns born before 34 weeks' gestation are outside the covered indication for iNO. Treatment in this population is unproven and not medically necessary under the policy.

INOmax is contraindicated in infants known to be dependent on right-to-left shunting. This safety restriction applies regardless of the proposed treatment indication.

Routine, rescue, or prophylactic iNO is not recommended for preterm infants born before 34 weeks who require respiratory support for respiratory failure or respiratory distress syndrome. This includes routine use to prevent bronchopulmonary dysplasia; an alternative indication, such as pulmonary hypoplasia or pulmonary hypertension, must be present for consideration under the cited guidance.

iNO should not be used routinely in newborns with congenital diaphragmatic hernia.

Use of iNO in infants with congenital diaphragmatic hernia, pulmonary hypertension, and significant left ventricular dysfunction is not recommended because of lack of response and potential cardiorespiratory failure.

Because of insufficient evidence of efficacy, iNO is unproven and not medically necessary for other newborn populations outside the covered term or near-term indications. This includes newborns with CDH and preterm newborns born before 34 weeks' gestation; the policy states that the list is not exhaustive.

Applicable Codes and Clinical Coding Parameters

Applicable CodesCPT

94799

Unlisted pulmonary service or procedure

Gestational age

Minimum gestational ageAt least 34 weeks' gestation at birth

Eligible populationTerm or near-term infants with hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn

Additional requirementFailure of conventional treatments, such as mechanical ventilation

Oxygenation index

Oxygenation index thresholdExceeds 25

Applicable populationTerm and near-term infants with PPHN or hypoxemic respiratory failure

Clinical purposeSupports iNO use to improve oxygenation and reduce the need for ECMO

Initial iNO concentration

Initial concentration20 ppm

Population studiedTerm and near-term infants

Clinical conditionHypoxic respiratory failure without diaphragmatic hernia

PPHN oxygenation threshold

PaO2 thresholdLess than 100 mm Hg

Oxygen supportWhile receiving 100% oxygen

Clinical useOne qualifying threshold for iNO treatment of PPHN in mechanically ventilated term or near-term newborns

PPHN oxygenation index threshold

Oxygenation index thresholdGreater than 25

PopulationMechanically ventilated term or near-term newborns with PPHN

Treatment objectiveImprove oxygenation and reduce the need for ECMO

CDH iNO response

Response criterionIncrease in PaO2 greater than 20 mm Hg

Clinical contextAssessment of iNO response in infants with congenital diaphragmatic hernia and pulmonary hypertension

Associated findingResponders had improved oxygenation; nonresponders were more likely to have left ventricular systolic dysfunction

Documentation and Denial-Risk Considerations

Documentation Required

Document PPHN Severity and Treatment Population

Document that the newborn has PPHN or hypoxic respiratory failure and is a term or near-term infant receiving mechanical ventilation. Record objective oxygenation data supporting treatment, including PaO2 while receiving 100% oxygen or the oxygenation index.

Gestational maturity: at least 34 weeks at birth.
Mechanical ventilation: document ventilator support.
Objective threshold: PaO2 less than 100 mm Hg while receiving 100% oxygen or oxygenation index greater than 25.

Documentation Required

Document Delivery and Monitoring System

Document the complete nitric oxide delivery and monitoring system used for treatment. The system must support administration with a ventilator or other mechanical gas administration system and monitoring of inspired oxygen, nitric oxide, and nitrogen dioxide with an alarm system.

Record the nitric oxide administration apparatus or cleared delivery device.
Document use of a nitric oxide gas analyzer and nitrogen dioxide gas analyzer.
Document calibration with a precise nitric oxide/nitrogen dioxide calibration mixture when applicable.
Document monitoring of inspired O2, NO2, and NO and operation of the alarm system.

Denial Risk

Confirm No CDH and Conventional-Treatment Failure

Before billing or requesting coverage, document that the newborn does not have congenital diaphragmatic hernia and that conventional treatments have failed. iNO is unproven and not medically necessary for newborns with congenital diaphragmatic hernia or when failure of conventional treatment has not been established.

Exclusion: congenital diaphragmatic hernia.
Required documentation: failure of conventional treatments, such as mechanical ventilation.
Exception: iNO may be covered as bridge therapy during acute recovery after heart or lung surgery in infants with associated pulmonary hypertension.

Denial Risk

Preterm Newborn Under 34 Weeks

Do not represent iNO as medically necessary for preterm newborns born at less than 34 weeks' gestation. Evidence does not demonstrate a clear clinically or statistically significant benefit for respiratory distress syndrome or prevention or treatment of bronchopulmonary dysplasia, and studies suggest possible harm.

Applies to newborns born at less than 34 weeks' gestation.
Includes treatment of respiratory distress syndrome.
Includes prevention or treatment of bronchopulmonary dysplasia (BPD).
Evidence suggests possible increased risks of grade 3 or 4 intraventricular hemorrhage and necrotizing enterocolitis.

Denial Risk

Outside Infancy Age Group

iNO treatment for individuals outside the Infancy age group is experimental or investigational because there are no U.S. Food and Drug Administration-approved indications applicable to that population.

Verify and document that the patient is within the policy's Infancy age group before treatment and billing.

Denial Risk

Verify Approved Population and Contraindications

Confirm that treatment is being used within the approved population and that no contraindication applies. INOmax is not approved for preterm infants at or below 34 weeks and is contraindicated in infants known to be dependent on right-to-left shunting.

Not approved: use in preterm infants ≤ 34 weeks.
Contraindication: known dependence on right-to-left shunting.
FDA approval alone is not a basis for coverage; apply the policy's medical-necessity criteria.

Documentation Required

PPHN Clinical Oxygenation Thresholds

For PPHN treatment, document that the patient is a mechanically ventilated term or near-term newborn and record the objective oxygenation threshold supporting iNO. Clinical practice guidance identifies treatment when either the PaO2 is less than 100 mm Hg while receiving 100% oxygen or the oxygenation index exceeds 25.

Population: term or near-term newborn, at least 34 weeks' gestation at birth.
Support: mechanically ventilated for PPHN.
PaO2 criterion: < 100 mm Hg while receiving 100% oxygen.
Oxygenation-index criterion: > 25.

Key Terms

Infancy

DefinitionThe period from birth through the first year of life

Age boundaryBegins at birth

End of periodEnds after the first year of life

BPD

Full termBronchopulmonary dysplasia

DefinitionA chronic lung condition of prematurity

Relevance to iNOEvaluated as an outcome of iNO therapy; routine iNO use has not been shown to prevent BPD in preterm infants

PPHN/PH

PPHNPersistent pulmonary hypertension of the newborn

PHPulmonary hypertension associated with neonatal or pediatric disease

FDA-indication contextiNO is used for hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension

CDH

Full termCongenital diaphragmatic hernia

DefinitionA neonatal condition in which iNO may provide temporary oxygenation improvement

Evidence contextNo established mortality or ECMO benefit; use is not recommended in infants with CDH, pulmonary hypertension, and significant left ventricular dysfunction

Full termOxygenation index

DefinitionAn objective measure used to assess oxygenation severity

Treatment roleAn oxygenation index greater than 25 is one qualifying criterion for iNO treatment of PPHN

Inhaled Nitric Oxide Therapy

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Inhaled Nitric Oxide Therapy

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Medical Necessity and Coverage Criteria

Applicable Codes and Clinical Coding Parameters

Documentation and Denial-Risk Considerations

Therapy Background

Key Terms