CurrentUnitedHealthcarePolicy CS173PA.K

Inhaled Nitric Oxide Therapy (for Pennsylvania Only)

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This Pennsylvania-only UnitedHealthcare Community Plan policy governs coverage and prior authorization review for inhaled nitric oxide therapy, primarily for infants with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for Pennsylvania Only)

Policy CodePolicy CS173PA.K

Change TypeAdministrative and reference updateno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateNot specified

Key ActionSubmit requests that do not meet the established criteria for case-by-case review by the Prior Authorization Review Panel.

SourceLink

POLICY UPDATE CHANGES

The Pennsylvania Code reference link for the exceptions provision was updated, and the clinical evidence and references sections were refreshed.

Pennsylvania onlyGeographic scope

≥34 weeksMinimum gestational age for standard covered indication

2Primary covered indications

Not covered

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CurrentUnitedHealthcarePolicy CS173PA.K

Inhaled Nitric Oxide Therapy (for Pennsylvania Only)

Customize your policy alerts

Sign up for UnitedHealthcare Policy CS173PA.K alerts

Get alerted when Policy CS173PA.K changes without checking for updates manually.

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Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for Pennsylvania Only)

Policy CodePolicy CS173PA.K

Change TypeAdministrative and reference updateno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateNot specified

Key ActionSubmit requests that do not meet the established criteria for case-by-case review by the Prior Authorization Review Panel.

SourceLink

POLICY UPDATE CHANGES

The Pennsylvania Code reference link for the exceptions provision was updated, and the clinical evidence and references sections were refreshed.

Pennsylvania onlyGeographic scope

≥34 weeksMinimum gestational age for standard covered indication

2Primary covered indications

Not covered

Medical Necessity and Coverage Criteria

Initial medically necessary therapy

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

Covered neonatal indication

Patient and indication
- Gestational age and clinical condition
  - Term or near-term infant
    The patient is a term or near-term infant born at least 34 weeks' gestation.Gestational age at birth >=34 weeks
  - Qualifying condition
    The patient has hypoxic respiratory failure.
    The patient has echocardiographic evidence of persistent pulmonary hypertension of the newborn.
- Additional requirements
  - The patient does not have congenital diaphragmatic hernia.
  - Conventional treatments, such as mechanical ventilation, have failed.
    Failure of conventional treatments is required.

Postoperative pulmonary hypertension bridge therapy

iNO will be covered as bridge therapy during the acute recovery phase when used in the postoperative management of pulmonary hypertension associated with heart or lung surgery in infants.

Postoperative bridge therapy

The patient is an infant undergoing postoperative management of pulmonary hypertension associated with heart or lung surgery.
iNO is used as bridge therapy during the acute recovery phase.
The policy identifies this as a clinically accepted option.

Unproven or not medically necessary newborn use

iNO is unproven and not medically necessary for other newborn uses, including the following.

Unproven newborn use

The patient is a preterm newborn born before 34 weeks' gestation.Gestational age at birth <34 weeks
The patient is a newborn with congenital diaphragmatic hernia.

Experimental or investigational use outside infancy

Use outside the defined infancy age group is experimental or investigational.

Non-infant use

The individual is outside the infancy age group.Age greater than the first year of life
Infancy is defined as the period from birth through the first year of life. Treatment outside this age group is considered experimental or investigational because of a lack of FDA-approved indications.

Term or near-term PPHN

EPPVDN indicates iNO for selected mechanically ventilated term or near-term newborns with PPHN when either oxygenation criterion is met.

Selected PPHN indication

The newborn is term or near-term, mechanically ventilated, and has persistent pulmonary hypertension of the newborn.
Either oxygenation criterion
- PaO2 is less than 100 mm Hg while the newborn is receiving 100% oxygen.PaO2 <100 mm Hg on 100% oxygen
- The oxygenation index exceeds 25.Oxygenation index >25

Preterm infants with confirmed pulmonary hypertension

EPPVDN states that iNO may be considered in selected preterm infants with respiratory failure and confirmed pulmonary hypertension.

Preterm respiratory failure with pulmonary hypertension

The infant is less than 34 weeks' gestation.Gestational age <34 weeks
The infant has respiratory failure.
The infant has confirmed pulmonary hypertension.
Usefulness and efficacy are less well established; EPPVDN class IIb recommendation, level of evidence C.

Postoperative pulmonary hypertension or right-heart failure

AHA/ATS guidance recommends iNO and/or inhaled prostacyclin in addition to conventional postoperative care for selected postoperative pulmonary hypertension emergencies.

Postoperative pulmonary hypertension emergency

The patient has a postoperative pulmonary hypertension crisis.
The patient has failure of the right side of the heart.

Newborns with congenital diaphragmatic hernia are not included in the covered indication for inhaled nitric oxide (iNO). This population is identified as unproven and not medically necessary.

iNO treatment for individuals outside infancy is excluded from medically necessary coverage and is considered experimental or investigational because of a lack of FDA-approved indications. Infancy is defined as birth through the first year of life.

Routine iNO should not be used for preterm babies receiving respiratory support for respiratory distress syndrome unless another indication, such as pulmonary hypoplasia or pulmonary hypertension, is present.

Early routine, early rescue, or later rescue iNO is not recommended for preterm infants younger than 34 weeks' gestation who require respiratory support.

The American Academy of Pediatrics states that neither rescue nor routine iNO in preterm infants with respiratory failure improves survival. Evidence also does not support iNO to prevent bronchopulmonary dysplasia, severe intraventricular hemorrhage, or other neonatal comorbidities.

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

Use of iNO is not recommended in infants with congenital diaphragmatic hernia, pulmonary hypertension, and significant left ventricular dysfunction. Available evidence did not demonstrate clear benefit and suggested possible harm for some combined outcomes.

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

iNO is unproven and not medically necessary for preterm newborns born before 34 weeks' gestation.

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

Applicable Code and Clinical Thresholds

Applicable Procedure CodeCPT

94799

Unlisted pulmonary service or procedure

Gestational age

Minimum gestational age at birthAt least 34 weeks for the covered neonatal indication

Oxygenation index

Oxygenation index thresholdExceeds 25 in term and near-term infants with PPHN or hypoxemic respiratory failure

EPPVDN PPHN oxygenation threshold

PaO2 thresholdLess than 100 mm Hg while receiving 100% oxygen

EPPVDN oxygenation index threshold

Authorization and Provider Review Guidance

Prior Authorization

Submit exceptions for case-by-case review

Requests for services that do not meet the criteria established by the Prior Authorization Review Panel (PARP) will be evaluated on a case-by-case basis. Refer to Pennsylvania Code § 55.1101.31(f) for exceptions.

Denial Risk

Avoid unsupported neonatal indications

Coverage is not medically necessary when iNO is requested for a newborn born before 34 weeks’ gestation or for a newborn with congenital diaphragmatic hernia. Coverage is also not medically necessary when conventional treatments, such as mechanical ventilation, have not failed.

Preterm newborns born before 34 weeks’ gestation are an unproven, not medically necessary population.
iNO is unproven and not medically necessary for newborns with congenital diaphragmatic hernia.
Document failure of conventional treatments before requesting iNO.

Clinical Background

Inhaled nitric oxide selectively dilates pulmonary vessels in ventilated lung regions, decreases pulmonary vascular resistance, and can improve oxygenation in neonatal hypoxic respiratory failure or persistent pulmonary hypertension of the newborn.

Policy Definitions

Infancy

InfancyThe period from birth through the first year of life