RetiredUnitedHealthcarePolicy CS173LA.A

Inhaled Nitric Oxide Therapy (for Louisiana Only)

Policy governing medical necessity and coverage of inhaled nitric oxide therapy for newborns in the state of Louisiana, specifying covered indications (term/near-term infants with hypoxic respiratory failure/PPHN) and populations considered unproven or investigational.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for Louisiana Only)

Policy CodePolicy CS173LA.A

Change TypeRetiredoperational and creation entries in this revision

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionVerify UnitedHealthcare plan requirements and prior authorization tools when determining coverage, as this policy was retired for Louisiana effective 04/01/2026.

SourceLink

POLICY UPDATE CHANGES

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

New Medical Policy created effective 02/01/2026.

Louisiana onlyApplies to

≥34wGestational threshold

20 ppmInitial iNO conc.

1 yearDefinition of infancy

94799

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Coverage Criteria for Inhaled Nitric Oxide (iNO)

Covered Indications (Term/Near-Term Infants)

Covered when ALL of the following are met:

Term or near-term infant: Infant is at least 34 weeks gestation at birth>= 34 weeks

Supported by randomized trials and meta-analyses demonstrating reduced death or need for ECMO in this population

Clinical condition: Hypoxic respiratory failure or clinical/echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN)

Indication aligned with trials and guideline recommendations

No congenital diaphragmatic hernia (CDH): Absence of congenital diaphragmatic hernia

Infants with CDH are excluded from this covered indication

Failure of conventional therapy: Failure of conventional treatments (e.g., mechanical ventilation, oxygen, CPAP) prior to initiation of iNO

iNO used as rescue/adjunct after conventional measures

Postoperative Bridge Therapy (Infants)

Covered when ALL of the following are met:

Postoperative pulmonary hypertension: iNO is used for postoperative management of pulmonary hypertension associated with cardiac or lung surgery in infants

Covered as bridge therapy during the acute recovery phase; AHA/ATS guidelines recommend iNO and/or inhaled prostacyclin as initial therapy for postoperative PH crises in addition to conventional care

Not Medically Necessary / Unproven Indications

iNO is considered not medically necessary or investigational for these groups:

Preterm infants: Preterm newborns less than 34 weeks gestation at birth< 34 weeks

Systematic reviews and RCTs fail to demonstrate clear benefit and suggest possible harms (e.g., grade 3–4 IVH, NEC); routine or rescue use not supported

Newborns with congenital diaphragmatic hernia (CDH): Infants with CDH

iNO is not covered for treatment of newborns with CDH; evidence does not show clear benefit for death or ECMO reduction

Individuals outside infancy: Persons outside the infancy age group (beyond first year of life)

Experimental/investigational due to lack of FDA-approved indications for these ages

Covered indications aligned with FDA and guideline recommendations

Coverage aligned with clinical evidence and FDA indication; examples of covered scenarios include:

FDA-indicated neonatal population: Term and near-term neonates (>34 weeks gestation) with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension (per INOmax FDA indication)gestational age >34 weeks

INOmax FDA indication for this population

Severe oxygenation impairment: Mechanically ventilated neonates with PaO2 < 100 mm Hg on 100% O2 OR oxygenation index > 25PaO2 <100 mm Hg; OI >25

EPPVDN consensus thresholds for iNO consideration

Postoperative PH crises: Postoperative pulmonary hypertension crises where initial therapy with iNO and/or inhaled prostacyclin is indicated in addition to conventional postoperative care

Not routinely covered / insufficient evidence

Uses not supported or not routinely recommended based on evidence summaries and specialty guidance:

Routine or rescue use in preterm infants: Routine or rescue administration of iNO for preterm infants (<34 weeks gestation) to prevent BPD or improve survivalgestational age <=34 weeks

Cochrane reviews, RCTs, and AAP/NIH guidance do not support routine or rescue use; possible increased risk of severe IVH and NEC reported

CDH — benefit uncertain: Use of iNO in newborns with congenital diaphragmatic herniaCDH population

Transient oxygenation improvements may occur but randomized trials/meta-analyses do not demonstrate improved survival or reduced ECMO and possible harms reported; therefore not routinely recommended

Inhaled nitric oxide (iNO) is specifically excluded for the treatment of newborns with congenital diaphragmatic hernia (CDH). The policy states that CDH is an exclusion from covered indications despite possible transient improvements in oxygenation in some reports; therefore iNO for CDH will be considered not covered for newborns with this diagnosis.

The FDA-labeled product INOmax® is indicated for treatment of term and near-term neonates (> 34 weeks gestation) with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension. INOmax is not approved for use in preterm infants (≤ 34 weeks), and the policy notes this regulatory limitation when considering coverage for infants born before 34 weeks gestation.

Use of iNO in preterm newborns (< 34 weeks gestation) and for indications outside the infancy period is considered unproven, investigational, or not medically necessary. Systematic reviews and randomized trials have not demonstrated a consistent clinical benefit for premature infants and some analyses suggest potential harms (for example, increased risk of severe intraventricular hemorrhage and possible increased necrotizing enterocolitis), supporting classification of these uses as investigational.

Routine or rescue administration of iNO in preterm infants (< 34 weeks gestation) to prevent bronchopulmonary dysplasia (BPD) or to improve survival is not supported by the evidence and therefore is not recommended. Major professional statements and reviews (including AAP guidance, Cochrane reviews, NIH consensus, and NICE guidance) conclude that neither routine nor rescue use improves survival or reliably prevents BPD in this population, and potential risks have been identified.

Coding and Clinical Thresholds

Referenced CPT CodesCPT

94799

Unlisted pulmonary service or procedure.

Affected codes (document does not list specific CPT/HCPCS)mixed

affected codes

Policy notes prior authorization and coding may be impacted; specific HCPCS/CPT codes not listed in this document portion.

inv-12: Oxygenation Index — > 25 (per AHA/ATS guideline recommendation for iNO use)

ThresholdOxygenation index (OI) > 25

ContextAHA/ATS guideline recommends iNO to reduce need for ECMO in term/near-term infants with PPHN or hypoxemic respiratory failure when OI > 25

Evidence basisClass I; Level of Evidence A (multiple randomized trials or meta-analyses)

inv-13: Oxygenation index — > 25

ThresholdOxygenation index (OI) > 25

Use caseEPPVDN indicates iNO is indicated in mechanically ventilated term/near-term newborns when OI > 25 to improve oxygenation and reduce ECMO need

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and plan verification

Prior Authorization/Plan Verification: This policy applied to Louisiana and was retired effective 04/01/2026. Verify the member's current UnitedHealthcare plan requirements and any prior authorization rules before initiating inhaled nitric oxide (iNO) therapy.

Retired for Louisiana effective 04/01/2026 — do not assume coverage based on this policy alone.
Check member-specific UnitedHealthcare plan benefit documents and prior authorization portals for current requirements.

Documentation Required

FDA approval and off-label use

FDA approval and off-label use: INOmax is FDA-cleared for treatment of term and near-term neonates (>34 weeks gestation) with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension. INOmax is not approved for use in preterm infants (≤34 weeks). Use of iNO outside the FDA‑cleared neonatal indication (including older children and adults) is considered experimental/investigational by this policy and may not be covered.

Background and Rationale

Inhaled nitric oxide causes pulmonary vasodilation, lowering pulmonary vascular resistance and improving ventilation–perfusion matching in ventilated neonates with pulmonary hypertension. In term and near-term infants with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn (PPHN), iNO has been shown to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) when used as an adjunct after conventional therapy. Clinicians should note that iNO administration requires appropriate delivery and monitoring systems (gas analyzers and calibrated delivery devices), and the FDA-regulated product INOmax® is labeled for term and near-term neonates (> 34 weeks) with clinical or echocardiographic evidence of pulmonary hypertension.

Definitions Used in This Policy

inv-24: Infancy — The period from birth through the first year of life

DefinitionInfancy is the period from birth through the first year of life

SourceBarfield 2016 as cited in policy definitions

Scope notePolicy applies to individuals within this age group for covered iNO indications

inv-25: Persistent pulmonary hypertension of the newborn (PPHN) — Definition for term/near-term newborns

DefinitionPersistent pulmonary hypertension of the newborn (PPHN): increased pulmonary vascular resistance, right-to-left shunting, and severe hypoxemia in term/near-term newborns

Clinical relevancePPHN may present with hypoxic respiratory failure and is an indication for iNO in selected term/near-term infants

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for Louisiana Only)

Policy CodePolicy CS173LA.A

Change TypeRetiredoperational and creation entries in this revision

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionVerify UnitedHealthcare plan requirements and prior authorization tools when determining coverage, as this policy was retired for Louisiana effective 04/01/2026.

SourceLink

On This Page

AHA/ATS guideline recommendation for postoperative PH management

Evidence levelCOE I; LOE A (data from multiple randomized trials or meta-analyses)

inv-14: PaO2 on 100% O2 — < 100 mm Hg

ThresholdPaO2 on 100% O2 < 100 mm Hg

Clinical implicationEPPVDN states iNO indicated in mechanically ventilated term/near-term infants if PaO2 < 100 mm Hg on 100% oxygen to improve oxygenation/reduce ECMO

Associated populationApplies to term and near-term (≥34 weeks) newborns with PPHN or hypoxic respiratory failure

INOmax indicated for term and near-term neonates (>34 weeks) with hypoxic respiratory failure and evidence of pulmonary hypertension.
INOmax is not approved for preterm infants (≤34 weeks); treatment in preterm newborns is considered not medically necessary by this policy.
Use outside the FDA indication (other ages/conditions) is experimental/investigational and may be excluded from coverage.

Documentation Required

Document gestational age and pulmonary hypertension evidence

Document gestational age and evidence of pulmonary hypertension: For term and near‑term infants receiving iNO, document the infant's gestational age at birth (must be ≥34 weeks per coverage rationale) and clinical or echocardiographic evidence of pulmonary hypertension or persistent pulmonary hypertension of the newborn (PPHN). Also document failure of conventional therapies when applicable.

Record gestational age at birth; infants <34 weeks are considered preterm and treatment is not supported by this policy.
Document clinical signs or echocardiographic evidence of pulmonary hypertension/PPHN (e.g., right‑to‑left shunting, elevated pulmonary vascular resistance).
Document prior failure of conventional treatments (oxygen, ventilation, surfactant, etc.) when iNO is used after other therapies.
For postoperative use as bridge therapy, document the surgical context and rationale for iNO as initial postoperative therapy for pulmonary hypertension crises.

Step Therapy

Step‑up use after conventional therapy

Step‑up use after conventional therapy and postoperative bridge therapy: iNO is indicated for term and near‑term infants after failure of conventional treatments and may be used as bridge therapy during acute postoperative recovery for pulmonary hypertension associated with heart or lung surgery.

iNO is appropriate after documented failure of conventional therapies (e.g., mechanical ventilation, oxygen, CPAP).
In postoperative pulmonary hypertension crises, document the use of iNO (and/or inhaled prostacyclin) as recommended by AHA/ATS guidelines.

Denial Risk

Denial triggers

Denial triggers and exclusion reminders: Do not use iNO for newborns with congenital diaphragmatic hernia (CDH) or for preterm newborns <34 weeks gestation — these indications are considered unproven or not medically necessary per this policy.

Treatment for newborns with CDH is considered unproven/not medically necessary.
Treatment for preterm newborns (<34 weeks gestation) is considered not medically necessary.

Billing Rule

Billing code reference

Billing code reference: The policy lists procedure codes for reference only; listing does not guarantee coverage or payment. Confirm applicable billing codes and reimbursement policies with the payer.

CPT 94799 — Unlisted pulmonary service or procedure (reference only).
Inclusion of a code in this policy does not imply coverage or guarantee reimbursement.

Diagnostic evidencePolicy requires clinical or echocardiographic evidence of pulmonary hypertension for treatment consideration

inv-26: INOmax indication — FDA-indicated for treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure

FDA indicationINOmax is indicated for treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension

Regulatory detailINOmax was initially cleared by FDA in December 1999 with multiple supplemental approvals; delivery systems cleared to administer iNO with monitoring

Contraindication noteINOmax is not approved for use in preterm infants (≤34 weeks) and is contraindicated in infants dependent on right-to-left shunting

inv-27: PPHN oxygenation thresholds (EPPVDN guidance) — EPPVDN states iNO indicated in mechanically ventilated term/near-term newborns when PaO2 threshold met

EPPVDN oxygenation thresholdsiNO indicated in mechanically ventilated term/near-term newborns when PaO2 < 100 mm Hg on 100% O2 or oxygenation index > 25

PurposeThresholds intended to identify infants who may benefit to improve oxygenation and reduce need for ECMO

Evidence classificationCOE I; LOE A (EPPVDN cites randomized trials/meta-analyses)