CurrentUnitedHealthcarePolicy CSNCT0607.05

Inhaled Nitric Oxide Therapy (for North Carolina Only)

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Coverage of inhaled nitric oxide therapy for North Carolina members, primarily term or near-term infants with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn; postoperative bridge therapy and noncovered newborn and non-infant uses are also addressed.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for North Carolina Only)

Policy CodePolicy CSNCT0607.05

Change TypeSupporting-information updateno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionDocument that the infant is at least 34 weeks' gestation, has hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension, lacks congenital diaphragmatic hernia, and has failed conventional treatment before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

The Clinical Evidence and References sections were updated to reflect the most current information.

North CarolinaApplicable state

≥34 weeksMinimum gestational age for covered initial treatment

20 ppmInitial iNO concentration

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CurrentUnitedHealthcarePolicy CSNCT0607.05

Inhaled Nitric Oxide Therapy (for North Carolina Only)

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Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for North Carolina Only)

Policy CodePolicy CSNCT0607.05

Change TypeSupporting-information updateno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

The Clinical Evidence and References sections were updated to reflect the most current information.

North CarolinaApplicable state

≥34 weeksMinimum gestational age for covered initial treatment

20 ppmInitial iNO concentration

Medical Necessity and Coverage Criteria

Initial therapy for term or near-term infants

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

Covered initial therapy

Population and treatment requirements
- The patient is a term or near-term infant born at least 34 weeks' gestation.≥34 weeks at birth
- The patient does not have congenital diaphragmatic hernia.
- The patient has failed conventional treatments, such as mechanical ventilation.
Covered clinical indication
- The patient has hypoxic respiratory failure.
- The patient has echocardiographic evidence of persistent pulmonary hypertension of the newborn.

Postoperative bridge therapy

Covered as an accepted option in the following postoperative circumstance:

In the postoperative management of pulmonary hypertension associated with heart or lung surgery in infants, iNO is covered as bridge therapy during the acute recovery phase.Acute recovery phase

Other newborn use

iNO is unproven and not medically necessary for:

Unproven or not medically necessary newborn use

Any newborn population outside the covered term or near-term criteria, including preterm newborns born at less than 34 weeks' gestation or newborns with congenital diaphragmatic hernia.Gestational age <34 weeks for the specifically listed preterm population
The examples are not exhaustive; the policy states including but not limited to these populations.

Treatment outside infancy

iNO is experimental or investigational for:

Non-infant use

Treatment of individuals outside the infancy age group.Beyond the first year of life
The policy cites a lack of U.S. Food and Drug Administration-approved indications as the basis for this classification.

Congenital diaphragmatic hernia (CDH) is excluded from the covered initial-treatment criteria for iNO. Covered initial therapy requires a term or near-term infant born at least 34 weeks’ gestation without CDH, along with the applicable clinical indication and failure of conventional treatment.

Preterm newborns born at less than 34 weeks’ gestation are included among populations for which iNO is considered unproven and not medically necessary, rather than covered initial therapy.

Routine, early rescue, or later rescue iNO is not recommended for preterm infants younger than 34 weeks’ gestation who require respiratory support for respiratory failure or respiratory distress syndrome. An exception may apply when another indication, such as pulmonary hypoplasia or pulmonary hypertension, is present; use for these indications in infants below 34 weeks is off label.

Routine iNO use is not recommended in newborns with congenital diaphragmatic hernia. Evidence has not demonstrated a meaningful improvement in net health outcomes beyond temporary oxygenation improvement, and possible harm remains a concern.

Use of iNO is not recommended in infants with congenital diaphragmatic hernia, pulmonary hypertension, and significant left ventricular dysfunction.

For informational purposes, INOmax is indicated for term and near-term neonates born greater than 34 weeks with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax is not approved for preterm infants at or below 34 weeks and is contraindicated in infants dependent on right-to-left shunting. FDA approval alone is not a basis for coverage.

iNO is unproven and not medically necessary for all other newborns outside the covered criteria, including preterm newborns born at less than 34 weeks’ gestation and newborns with congenital diaphragmatic hernia. Treatment outside the infancy age group is experimental or investigational because of a lack of FDA-approved indications.

Applicable Codes and Clinical Thresholds

Applicable CodesCPT

94799

Unlisted pulmonary service or procedure

Gestational age at birth

Covered populationTerm or near-term infants

Gestational age at birthAt least 34 weeks

Additional requirementHypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn

Oxygenation index

Oxygenation indexExceeds 25

PopulationTerm and near-term infants

Clinical indications

Provider and Coverage Decision Guidance

Denial Risk

Confirm the infant meets the covered population criteria

Coverage may be denied when iNO is used for an infant born before 34 weeks’ gestation, for a newborn with congenital diaphragmatic hernia, or when conventional treatments such as mechanical ventilation have not failed. Treatment of individuals outside the infancy age group is experimental or investigational.

Confirm birth gestational age is at least 34 weeks for the covered initial-treatment population.
Establish absence of congenital diaphragmatic hernia.
Document failure of conventional treatments, such as mechanical ventilation.

Denial Risk

Establish medical necessity before initiating iNO

Coverage may be denied when the newborn does not have hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn, or when the required absence of congenital diaphragmatic hernia and failure of conventional treatment are not established.

Clinical Background

Inhaled nitric oxide (iNO) is a gaseous pulmonary vasodilator that dilates blood vessels in ventilated regions of the lung and decreases pulmonary vascular resistance. By improving blood flow to ventilated lung regions, iNO can improve oxygenation in hypoxic respiratory failure. The policy focuses on selected term and near-term newborns with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn, while recognizing potential risks such as increased methemoglobin.

Key Terms

Infancy

TermInfancy

DefinitionThe period from birth through the first year of life

Coverage relevanceTreatment outside the infancy age group is classified separately from newborn treatment

PPHN

AbbreviationPPHN

DefinitionPersistent pulmonary hypertension of the newborn

Relevance to iNOIn selected mechanically ventilated term or near-term newborns, iNO may improve oxygenation and reduce the need for ECMO