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    v1.0.30
    OpenPayerPolicy UpdatesPediatrics/NeonatologyUnitedHealthcare iNO Infant Coverage | OpenPayer
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    CurrentUnitedHealthcarePolicy CS173KY.09

    Inhaled Nitric Oxide Therapy (for Kentucky Only)

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    This policy governs coverage of inhaled nitric oxide therapy for infants and newborns treated in Kentucky. It defines medically necessary indications, excluded or unproven populations, and applicable coding guidance for UnitedHealthcare Community Plan providers.

    Policy Summary
    PayerUnitedHealthcare
    PolicyInhaled Nitric Oxide Therapy (for Kentucky Only)
    Policy CodePolicy CS173KY.09
    Change TypeNo material change
    Effective DateOctober 1, 2026
    Next Review DateN/A
    Key ActionDocument gestational age at birth, qualifying respiratory or pulmonary hypertension findings, absence of congenital diaphragmatic hernia, and failure of conventional treatment.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥34 weeksMinimum gestational age for the principal covered indication
    <34 weeksPreterm population for which iNO is unproven and not medically necessary
    20 ppmInitial iNO concentration supported for term and near-term infants
    PaO₂ <100 mm Hg or OI >25

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    PPHN threshold
    ≤34 weeksPreterm group not supported for routine iNO

    Medical Necessity and Coverage Criteria

    Medically necessary covered indications

    Covered when at least one of the following pathways is met:

    Covered pathways

    • Standard newborn indication

      • Required standard criteria: The infant was born at least 34 weeks gestation; has hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn; does not have congenital diaphragmatic hernia; and has failed conventional treatments such as mechanical ventilation.Gestational age ≥34 weeks at birth

        All four criteria are required.

    • Postoperative bridge therapy: The infant has pulmonary hypertension associated with heart or lung surgery and inhaled nitric oxide is used during the acute postoperative recovery phase as bridge therapy.Acute recovery phase

      This is a clinically accepted covered option.

    Not medically necessary or unproven newborn use

    Unproven and not medically necessary when any of the following applies:

    Unproven newborn uses

    • Preterm newborn: The newborn was born at less than 34 weeks gestation.<34 weeks gestation at birth

      Efficacy is insufficiently established for this population.

    • Congenital diaphragmatic hernia: The newborn has congenital diaphragmatic hernia.

      iNO treatment for newborns with congenital diaphragmatic hernia is unproven and not medically necessary.

    • Other newborn use: The newborn does not meet the covered term or near-term clinical indication.

      Due to insufficient evidence of efficacy, other newborn uses are unproven and not medically necessary.

    Treatment outside infancy

    Experimental or investigational:

    Outside infancy: The individual is outside the infancy age group.After the first year of life

    Infancy is the period from birth through the first year of life. Treatment outside infancy is experimental or investigational because there are no FDA-approved indications for this population.

    PPHN in mechanically ventilated term or near-term newborns

    EPPVDN indicates inhaled nitric oxide for PPHN when all of the following are present:

    Guideline-supported PPHN indication

    • Patient and treatment setting: The newborn is term or near-term and is receiving mechanical ventilation.Term or near-term; mechanically ventilated

    • Hypoxemia severity

      • PaO2 is less than 100 mm Hg while receiving 100% oxygen.PaO2 <100 mm Hg while receiving 100% oxygen
      • The oxygenation index exceeds 25.Oxygenation index >25

    Postoperative pulmonary hypertension crisis or right-heart failure

    AHA/ATS recommends inhaled nitric oxide and/or inhaled prostacyclin as initial therapy in addition to conventional postoperative care when:

    Postoperative pulmonary hypertension emergency

    • The patient has a postoperative pulmonary hypertension crisis after heart or lung surgery.Pulmonary hypertension crisis
    • The patient has failure of the right side of the heart after heart or lung surgery.Right-heart failure

    Preterm infant with confirmed pulmonary hypertension

    EPPVDN states that inhaled nitric oxide may be considered in selected preterm infants when all of the following are present:

    Selected preterm pulmonary hypertension use

    • The infant is preterm and younger than 34 weeks' gestation.<34 weeks' gestation
    • The infant has respiratory failure.

      This is not a routine indication for respiratory failure alone.

    • The infant has confirmed pulmonary hypertension.

      Efficacy is not well established; EPPVDN class IIb, level C.

    Congenital diaphragmatic hernia (CDH) is not included in the standard covered indication for inhaled nitric oxide (iNO). iNO treatment for newborns with CDH is identified as unproven and not medically necessary.

    Preterm newborns born at less than 34 weeks’ gestation are outside the medically necessary indication for iNO and are considered unproven because of insufficient evidence of efficacy.

    iNO treatment for individuals outside infancy—the period from birth through the first year of life—is considered experimental or investigational because there are no FDA-approved indications for that population.

    Routine, early rescue, or later rescue iNO is not recommended for preterm infants born at less than 34 weeks’ gestation who require respiratory support. Available guidance does not show improved survival or prevention of bronchopulmonary dysplasia with these approaches.

    Routine iNO should not be used for preterm babies requiring respiratory support for respiratory distress syndrome, unless another indication—such as pulmonary hypoplasia or pulmonary hypertension—is present. Routine iNO use in newborns is also not supported for respiratory support alone.

    iNO is not recommended for infants with congenital diaphragmatic hernia, pulmonary hypertension, and significant left ventricular dysfunction. Further studies are needed to identify patient characteristics and echocardiographic findings that may predict response.

    INOmax is contraindicated in infants known to be dependent on right-to-left shunting.

    INOmax is not approved for use in preterm infants at or below 34 weeks’ gestation. The FDA-indicated population is term and near-term neonates, defined in the product information as greater than 34 weeks, with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension.

    Because evidence of efficacy is insufficient, iNO is unproven and not medically necessary for newborns outside the covered term or near-term population. Evidence reviews and randomized trials have not established meaningful improvement in survival, bronchopulmonary dysplasia, neurodevelopmental outcomes, or other major respiratory outcomes for routine or rescue treatment in preterm infants with respiratory failure.

    iNO treatment for newborns with congenital diaphragmatic hernia is unproven and not medically necessary. Evidence suggests that any benefit is limited to temporary oxygenation improvement, without demonstrated benefit for mortality or need for extracorporeal membrane oxygenation; possible harm remains a concern.

    Evidence reviews and randomized trials evaluating iNO in preterm infants did not demonstrate meaningful improvement in survival, bronchopulmonary dysplasia, neurodevelopmental outcomes, or major respiratory outcomes. Studies of early rescue, routine treatment, and later treatment for increased BPD risk generally found no clinically significant benefit, and some analyses raised concern for severe intraventricular hemorrhage.

    Evidence does not support routine iNO use in newborns with congenital diaphragmatic hernia. Systematic reviews and randomized trials found no demonstrated benefit beyond temporary oxygenation improvement, while some analyses suggested possible harm for the combined outcome of death or ECMO use. The AARC guideline recommends against routine iNO in newborns with CDH.

    Applicable Codes and Clinical Thresholds

    Applicable CodesCPT
    94799Unlisted pulmonary service or procedure
    PaO2 for PPHN
    PaO2 thresholdLess than 100 mm Hg
    Oxygen administrationThreshold applies while receiving 100% oxygen
    Clinical contextEPPVDN criterion for iNO in mechanically ventilated term and near-term newborns with PPHN
    Oxygenation Index for PPHN
    Oxygenation index thresholdGreater than 25
    Clinical contextEPPVDN criterion for iNO treatment of PPHN
    Patient population

    Documentation and Denial Risks

    Documentation Required

    Document clinical eligibility

    Document gestational age at birth, hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn, absence of congenital diaphragmatic hernia, and failure of conventional treatments.

    Documentation Required

    Document postoperative bridge therapy

    For postoperative pulmonary hypertension associated with heart or lung surgery in an infant, document the postoperative setting and use of iNO as bridge therapy during the acute recovery phase.

    Denial Risk

    Confirm the covered population and diagnosis

    Clinical Background

    Inhaled nitric oxide (iNO) is a gaseous pulmonary vasodilator that dilates pulmonary vessels in ventilated areas and decreases pulmonary vascular resistance. In selected newborns with hypoxic respiratory failure or persistent pulmonary hypertension, it may improve oxygenation and reduce the need for extracorporeal membrane oxygenation. Potential harms include increased methemoglobin levels and an association with increased childhood cancer risk, which should be weighed against demonstrated benefits.

    Key Clinical Definitions

    Infancy
    DefinitionThe period from birth through the first year of life
    Starting pointBirth
    Ending pointCompletion of the first year of life
    PPHN
    AbbreviationPPHN means persistent pulmonary hypertension of the newborn
    EPPVDN populationMechanically ventilated term and near-term newborn infants
    iNO treatment contextiNO is indicated to improve oxygenation and reduce the need for ECMO when PaO2 is less than 100 mm Hg while receiving 100% oxygen or the oxygenation index exceeds 25
    Policy Summary
    PayerUnitedHealthcare
    PolicyInhaled Nitric Oxide Therapy (for Kentucky Only)
    Policy CodePolicy CS173KY.09
    Change TypeNo material change
    Effective DateOctober 1, 2026
    Next Review DateN/A
    Key ActionDocument gestational age at birth, qualifying respiratory or pulmonary hypertension findings, absence of congenital diaphragmatic hernia, and failure of conventional treatment.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaApplicable Codes and Clinical ThresholdsDocumentation and Denial RisksClinical BackgroundKey Clinical Definitions
    Mechanically ventilated term and near-term newborns
    Initial iNO Dose Evaluated for Prevention of BPD
    Initial doses evaluated5 ppm or 10 ppm
    BPD findingThe 10 ppm group had a significantly lower incidence of BPD than the control group; the 5 ppm group did not show a significant difference
    Study populationPreterm infants requiring respiratory support, including infants at or below 34 weeks of gestation
    Gestational Age in Long-Term EUNO Follow-up
    Gestational-age range24 to 28 weeks plus 6 days of gestation
    Follow-up durationOutcomes were assessed at 7 years of age
    Study population assessed305 children from the EUNO trial follow-up were assessed

    Coverage may be denied when the infant is younger than 34 weeks gestation at birth, has congenital diaphragmatic hernia, or does not have hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn.

    Denial Risk

    Establish failure of conventional treatment

    Coverage may be denied when conventional treatments, such as mechanical ventilation, have not failed. Document the failure of conventional treatment before requesting coverage.

    Denial Risk

    Treatment outside infancy may be denied

    Treatment outside the infancy age group is considered experimental or investigational because there are no FDA-approved indications for that population.

    Denial Risk

    Unproven newborn use may be denied

    Treatment for newborns outside the covered term or near-term population, including newborns with congenital diaphragmatic hernia, is unproven and not medically necessary due to insufficient evidence of efficacy.

    CDH
    AbbreviationCDH means congenital diaphragmatic hernia
    Oxygenation effectiNO may provide temporary oxygenation improvement in some newborns with CDH
    Evidence contextiNO has not demonstrated clear benefit on mortality or ECMO use, and routine use may be ineffective or potentially harmful
    BPD
    AbbreviationBPD means bronchopulmonary dysplasia
    Clinical roleBPD is a chronic pulmonary outcome evaluated in studies of iNO use in premature infants
    Evidence contextStudies evaluated whether iNO could prevent or reduce BPD, including systematic reviews and long-term follow-up
    Complete Nitric Oxide Delivery System
    Administration componentNitric oxide administration apparatus
    Monitoring componentsNitric oxide gas analyzer and nitrogen dioxide gas analyzer
    Total componentsThree required components: an administration apparatus, a nitric oxide gas analyzer, and a nitrogen dioxide gas analyzer
    Hypoxic Respiratory Failure
    DefinitionA neonatal condition involving inadequate oxygenation
    INOmax populationTerm and near-term neonates older than 34 weeks
    Associated findingClinical or echocardiographic evidence of pulmonary hypertension