CurrentUnitedHealthcarePolicy CS173NM.D

Inhaled Nitric Oxide Therapy (for New Mexico Only)

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This policy governs coverage of inhaled nitric oxide therapy for UnitedHealthcare Community Plan members in New Mexico, including medically necessary use in eligible infants with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn and noncovered or investigational uses in other populations.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for New Mexico Only)

Policy CodePolicy CS173NM.D

Change TypeAdministrative revisionno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionVerify applicable federal, state, and contractual benefit requirements before determining coverage.

SourceLink

POLICY UPDATE CHANGES

Supporting clinical evidence and reference sections were updated to reflect current information.

New MexicoApplicable state

≥34 weeksMinimum gestational age

20 ppmInitial concentration

>25Oxygenation index threshold

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CurrentUnitedHealthcarePolicy CS173NM.D

Inhaled Nitric Oxide Therapy (for New Mexico Only)

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Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for New Mexico Only)

Policy CodePolicy CS173NM.D

Change TypeAdministrative revisionno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionVerify applicable federal, state, and contractual benefit requirements before determining coverage.

SourceLink

POLICY UPDATE CHANGES

Supporting clinical evidence and reference sections were updated to reflect current information.

New MexicoApplicable state

≥34 weeksMinimum gestational age

20 ppmInitial concentration

>25Oxygenation index threshold

Medical Necessity and Coverage Criteria

Initial therapy for term or near-term infants

Covered when the infant meets the indication and all listed conditions are satisfied.

Covered primary indication

Eligibility requirements
- Gestational age: Infant is born at least 34 weeks' gestation.≥34 weeks
- Covered clinical indication: Infant has hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn.
- Additional conditions: The infant does not have congenital diaphragmatic hernia and has failed conventional treatments, such as mechanical ventilation.No congenital diaphragmatic hernia; failure of conventional treatment

Postoperative bridge therapy

Covered as an accepted bridge option during acute postoperative recovery.

Postoperative bridge therapy: In the postoperative management of pulmonary hypertension associated with heart or lung surgery in infants, inhaled nitric oxide is a clinically accepted option and is covered as bridge therapy during the acute recovery phase.Acute recovery phase after heart or lung surgery

The policy describes this as an option for infants with postoperative pulmonary hypertension.

Unproven, not medically necessary, or investigational uses

Not medically necessary or investigational for the following populations.

Unproven or investigational uses

Newborn exclusions: Newborn is born at less than 34 weeks' gestation or has congenital diaphragmatic hernia.<34 weeks or congenital diaphragmatic hernia
Age-related investigational use: Individual is outside the infancy age group.Outside the period from birth through the first year of life
Infancy is the period from birth through the first year of life.

PPHN clinical indication

EPPVDN clinical indication for PPHN; this is clinical guidance rather than an explicit payer coverage criterion.

Mechanically ventilated term or near-term newborn with PPHN

Severe oxygenation impairment
- 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

AHA/ATS postoperative clinical guidance; this is not stated as a payer-specific coverage criterion.

Postoperative pulmonary hypertension crisis or right-heart failure: In addition to conventional postoperative care, inhaled nitric oxide and/or inhaled prostacyclin may be used as initial therapy for pulmonary hypertension crises and failure of the right side of the heart.

Class I; level of evidence B.

Congenital diaphragmatic hernia is excluded from the covered term or near-term infant indication for inhaled nitric oxide.

Preterm newborns born at less than 34 weeks' gestation are excluded from the proven and medically necessary indication for inhaled nitric oxide.

Use of inhaled nitric oxide outside the infancy age group is considered experimental or investigational because there are no U.S. Food and Drug Administration-approved indications for that population.

Routine, early rescue, or later rescue use of inhaled nitric oxide is not recommended for preterm infants born at less than 34 weeks' gestation who require respiratory support. Evidence does not show improved survival or support use to prevent bronchopulmonary dysplasia or severe intraventricular hemorrhage.

Inhaled nitric oxide should not be used routinely for preterm babies requiring respiratory support for respiratory distress syndrome unless another indication—such as pulmonary hypoplasia or pulmonary hypertension—is present.

Inhaled nitric oxide should not be used routinely in newborns with congenital diaphragmatic hernia.

Inhaled nitric oxide is not recommended for infants with congenital diaphragmatic hernia, pulmonary hypertension, and significant left ventricular dysfunction.

For informational purposes, FDA labeling identifies INOmax for term and near-term neonates born at 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 known to be dependent on right-to-left shunting. FDA approval alone is not a basis for coverage.

Inhaled nitric oxide is unproven and not medically necessary for newborns born at less than 34 weeks' gestation.

Inhaled nitric oxide is unproven and not medically necessary for newborns with congenital diaphragmatic hernia.

Applicable Code and Clinical Thresholds

Applicable CodeCPT

94799

Unlisted pulmonary service or procedure

Gestational age at birth

Gestational age at birthAt least 34 weeks

Oxygenation index

Oxygenation indexGreater than 25

PaO2 threshold for PPHN

PaO2 threshold for PPHNLess than 100 mm Hg while receiving 100% oxygen

Oxygenation index threshold for PPHN

Coverage Verification and Denial Risks

Documentation Required

Verify governing benefit requirements

Before using this policy to determine coverage, check the applicable federal, state, or contractual requirements for benefit plan coverage. If those requirements conflict with this policy, the federal, state, or contractual requirements govern.

Denial Risk

Avoid noncovered populations and indications

Coverage may be denied when the infant was born at less than 34 weeks’ gestation, has congenital diaphragmatic hernia, or does not have hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn with failure of conventional treatment. Use outside the infancy age group is considered experimental or investigational.

Confirm gestational age at birth is at least 34 weeks.
Confirm the covered indication: hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn.

Therapy Overview

Inhaled nitric oxide dilates pulmonary vessels in ventilated areas and decreases pulmonary vascular resistance. It is used in selected newborns with hypoxic respiratory failure or persistent pulmonary hypertension to improve oxygenation and reduce the need for extracorporeal membrane oxygenation. Potential harms include increased methemoglobin levels and a reported more than eight-fold risk of childhood cancer; benefits and risks should therefore be weighed in the selected infant populations described by the policy.

Policy Definitions

Infancy

InfancyThe period from birth through the first year of life