CurrentUnitedHealthcarePolicy 2026T0607M

Inhaled Nitric Oxide Therapy

Medical policy governing coverage and clinical indications for inhaled nitric oxide therapy for UnitedHealthcare Commercial and Individual Exchange plans, with emphasis on neonatal use.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy

Policy CodePolicy 2026T0607M

Change TypeTemplate update (administrative)

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization documenting gestational age, diagnosis of hypoxic respiratory failure or PPHN, absence of CDH, and failure of conventional treatments before iNO for newborns meeting coverage criteria.

SourceLink

POLICY UPDATE CHANGES

Template Update noted in Policy History/Revision Information on 01/01/2026.

≥34 wksgestational age threshold for proven medically necessary use

20 ppmiNO initial concentration supported

mixedpreterm (<34 wks) outcomes

94799CPT code listed

01/01/2026policy history entry date

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Inhaled Nitric Oxide (iNO)

Postoperative pulmonary hypertension in infants with CHD — individualized bridge therapy

Postoperative pulmonary hypertension in infants with congenital heart disease (CHD) or following cardiothoracic surgery — covered as individualized bridge therapy during acute recovery when ALL of the following are met:

ALL of the following

Patient is an infant in the infancy age group (term or near-term as defined elsewhere in this policy) or a neonate recovering from cardiac or lung surgery
Clinical diagnosis of postoperative pulmonary hypertension (elevated pulmonary arterial pressures or clinical signs of pulmonary hypertensive crisis) documented by hemodynamic monitoring or echocardiography
iNO is being used as short-term bridge therapy during the acute postoperative recovery phase to stabilize oxygenation and right ventricular function, not as chronic or long-term therapy
Conventional postoperative management strategies have been instituted (e.g., optimization of ventilation, oxygenation, hemodynamic support), and iNO is added to address persistent or refractory pulmonary hypertension or pulmonary hypertensive crisis
The treating provider documents the anticipated short-term treatment goal and a plan for frequent reassessment and weaning of iNO as pulmonary hemodynamics and oxygenation improve
There is no contraindication to iNO use (for example, known dependence on right-to-left shunting without appropriate cardiac evaluation) or other clinical circumstance where iNO would be expected to cause harm

ONE of the following operational notes applies

Use may be considered for infants of any gestational age when pulmonary hypertension is directly related to the postoperative period following corrective or palliative cardiac or lung surgery and the intent is temporary stabilization
For infants with significant left ventricular systolic or diastolic dysfunction, iNO should be used with caution or avoided because pulmonary vasodilation may increase pulmonary venous return and precipitate cardiorespiratory failure; alternative strategies should be considered and documented
Duration of therapy should be limited to the acute recovery period; continuation beyond the immediate postoperative stabilization phase requires re-evaluation and documented justification

Documentation requirements

Indication for postoperative iNO with supporting clinical data (vital signs, blood gas, ventilator settings, echocardiogram or catheterization data)
Pre-therapy assessment including evaluation for left ventricular dysfunction or contraindications
Daily progress notes documenting response to iNO (improvement in oxygenation, pulmonary pressures, or hemodynamics) and active plan for weaning/discontinuation

Coding and Clinical Thresholds

Listed CPT CodeCPT

94799

Unlisted pulmonary service or procedure

Regulated products and delivery systems referencedmixed

INOmax (brand)	FDA-cleared nitric oxide gas product (not a numeric billing code; device/drug reference)
Noxivent / GeNOsyl	FDA-cleared nitric oxide delivery devices (device references)

inv-16: Oxygenation Index — clinical threshold

Oxygenation Index threshold> 25 (AHA/ATS guideline recommendation for initiating iNO in PPHN)

Clinical implicationOI > 25 indicates severe hypoxemic respiratory failure and supports use of iNO to reduce need for ECMO (Class I; LOE A)

Reference contextRecommendation applies to term and near-term infants with PPHN or hypoxemic respiratory failure

inv-17: Initial iNO concentration supported

Initial iNO concentration supported20 ppm

Population specifiedTerm and near-term infants with hypoxic respiratory failure (without diaphragmatic hernia)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Coding

Prior authorization is required for inhaled nitric oxide (iNO) therapy. Submit documentation that supports the indication, gestational age at birth, relevant diagnosis codes, and clinical status (including oxygenation indices or PaO2). Confirm coding accuracy (e.g., CPT 94799 where applicable) and attach member-specific benefit information; benefit terms govern coverage decisions.

Prior authorization required before initiation of iNO
Include procedure/diagnosis coding and member benefit info

Prior Authorization

iNO Prior Authorization Requirements

iNO prior authorization will be approved for term or near-term neonates only when all of the following are documented: gestational age ≥ 34 weeks at birth; clinical or echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN) or hypoxic respiratory failure; and objective oxygenation criteria (e.g., PaO2 and/or oxygenation index) or failure to oxygenate on conventional therapy.

Document gestational age ≥ 34 weeks

Definitions

inv-32: Infancy — period from birth through first year

DefinitionInfancy = the period from birth through the first year of life.

Clinical relevancePolicy coverage criteria for neonatal iNO use reference the infancy period for eligibility (term/near-term infants).

SourceBarfield 2016 definition as cited in policy definitions section.

inv-33: Hypoxic respiratory failure / PPHN — clinical or echocardiographic evidence definition

Core definitionClinical or echocardiographic evidence of pulmonary hypertension with significant hypoxemia (e.g., low PaO2 or elevated oxygenation index).

Common manifestationsPersistent pulmonary hypertension of the newborn (PPHN) presents with hypoxic respiratory failure and elevated pulmonary vascular resistance leading to right-to-left shunting.

Background and Clinical Evidence Summary

Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator delivered as a gas to ventilated lung regions; it reduces pulmonary vascular resistance and can improve oxygenation in hypoxic respiratory failure and persistent pulmonary hypertension of the newborn (PPHN). In term and near-term infants (≥ 34 weeks gestation) with PPHN, iNO reduces the need for extracorporeal membrane oxygenation (ECMO) and is considered medically necessary when conventional therapies have failed. iNO may also be used as individualized bridge therapy for postoperative pulmonary hypertension after cardiac or lung surgery in infants. Potential adverse effects include increased methemoglobin levels and safety concerns reported in some long-term observational studies; evidence in preterm infants and in congenital diaphragmatic hernia remains mixed or unfavorable.

Policy Revision History

2026-01-01template updateLatest

Template update to the policy document (Policy History/Revision Information entry).

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy

Policy CodePolicy 2026T0607M

Change TypeTemplate update (administrative)

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Evidence noteRCTs cited conclude iNO at 20 ppm is effective for improving oxygenation in this group

inv-18: PaO2 / Oxygenation index example thresholds used in guidance

PaO2 threshold examplePaO2 < 100 mm Hg while receiving 100% oxygen (per EPPVDN)

Oxygenation Index exampleOxygenation index > 25 (per EPPVDN and AHA/ATS guidance)

Use caseEither PaO2 <100 mm Hg on 100% O2 or OI >25 may be used to justify initiating iNO in mechanically ventilated term/near-term infants

Provide clinical or echocardiographic evidence of pulmonary hypertension or PPHN

Provide oxygenation indices (PaO2, OI) or clear failure of conventional therapy

Denial Risk

Denial Risk for CDH and Preterm Infants

iNO is considered not medically necessary (denial risk) for infants with congenital diaphragmatic hernia (CDH) and for preterm infants born < 34 weeks gestation. Denials may be issued when these conditions are present unless compelling, documented exceptions are approved by plan medical review.

iNO not covered for newborns with CDH
iNO not approved for preterm infants ≤ 34 weeks (INOmax labeling)

Documentation Required

Documentation Requirements

Provide clear documentation of gestational age, clinical findings, and diagnostic testing. Essential records include birth records noting gestational age, echocardiography reports documenting pulmonary hypertension, arterial blood gas values or PaO2, and calculated oxygenation index (OI) when available.

Birth records confirming gestational age
Echocardiogram report showing clinical/echocardiographic evidence of PH/PPHN
Arterial blood gas, PaO2, and/or oxygenation index (OI) values

Documentation Required

Conventional Therapy Prior to iNO

Before initiation of iNO, conventional therapies should be attempted and documented. These include supplemental oxygen, continuous positive airway pressure (CPAP), conventional or high-frequency mechanical ventilation, and surfactant therapy in preterm infants where applicable. For term/near-term infants, document that conventional respiratory support has failed to achieve adequate oxygenation.

Document trials of oxygen therapy and CPAP
Document mechanical ventilation attempts (conventional or high-frequency)
Document surfactant administration in preterm infants when indicated

Documentation Required

Consideration of Conventional Therapies and Escalation Plan

Include an escalation plan and clear evidence that conventional therapies were considered and/or attempted prior to and during iNO therapy. For postoperative pulmonary hypertension, describe the bridge therapy rationale and supporting perioperative clinical context.

Describe escalation plan and timing of interventions
For postoperative PH, document rationale for bridge therapy and clinical course

Role in coveragePresence of clinical or echo evidence of PH is required to meet criteria for iNO in term/near-term infants per policy and FDA labeling.

inv-34: Congenital diaphragmatic hernia (CDH) — definition and role of iNO

DefinitionCongenital diaphragmatic hernia (CDH) is a birth defect with pulmonary hypoplasia and pulmonary hypertension.

iNO effectiNO may transiently improve oxygenation in CDH but randomized trials and systematic reviews have not demonstrated benefit on death or need for ECMO; possible harm has been suggested.

Clinical cautionUse in CDH should be selective and individualized; avoid when significant left ventricular systolic dysfunction is present due to risk of deterioration.

inv-35: Inhaled nitric oxide (iNO) — definition

DefinitionInhaled nitric oxide (iNO) is a selective pulmonary vasodilator administered as gaseous nitric oxide to improve ventilation–perfusion matching and reduce pulmonary vascular resistance in ventilated lung regions.

Clinical uses citedEvaluated for neonates with pulmonary hypertension or hypoxic respiratory failure, and studied in preterm infants and those with CDH.

Regulatory/devicesiNO is delivered via FDA-cleared delivery systems that monitor inspired O2, NO and NO2; INOmax is an FDA-approved nitric oxide gas product for term/near-term neonates.