Inhaled Nitric Oxide Therapy (for Idaho Only)
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This policy governs medical necessity and coverage of inhaled nitric oxide (iNO) therapy for members of UnitedHealthcare Community Plan in the state of Idaho, including Idaho Medicaid Plus plans. It addresses indications in newborns and other populations and provides supporting evidence and coding references.
Updated Clinical Evidence and References sections to reflect the most current information.
Added instruction to refer to the Idaho Medicaid Provider Handbook, General Information and Requirements for Providers: Non-Covered and Excluded Services for additional information on non-covered and excluded services.
Archived previous policy version CS173ID.A.
Coverage Criteria for Inhaled Nitric Oxide (iNO)
Covered Indication — Term or Near-Term Infants with Hypoxic Respiratory Failure or PPHN
Covered when ALL of the following are met
Infancy defined as birth through first year of life
Infants with CDH are excluded from proven benefit
iNO may be used as bridge therapy postoperatively for pulmonary hypertension associated with heart or lung surgery in infants
Guideline-Referenced Use
Supporting guidance
AAP policy statement (2000; reaffirmed 2010) and related guidance
AHA/ATS: Class I; Level of Evidence A
EPPVDN consensus statement (Hansmann et al., 2019)
Evidence-based coverage considerations
Clinical evidence and guideline-based considerations summarized:
Cochrane review (Barrington et al., 2017) and RCTs (e.g., Hasan et al., 2017); NIH and AAP guidance advise against routine/early use in <34 weeks
Subgroup results are not conclusive and do not establish routine use
Consistent with FDA labeling and guideline recommendations
Consider echocardiographic predictors of response; avoid use when significant left ventricular dysfunction is present
May be used as bridge therapy during acute recovery
iNO is considered unproven and not medically necessary for newborns with congenital diaphragmatic hernia (CDH) and for preterm newborns who are less than 34 weeks gestation. The policy states that available evidence does not demonstrate consistent benefit for these populations and identifies potential harms in some preterm trials, supporting exclusion of CDH and preterm (<34 weeks) neonates from the covered indication for iNO.
Documentation of gestational age and absence of CDH is required to establish eligibility for the covered neonatal indication; claims for iNO in these excluded groups may be denied as unproven, investigational, or not medically necessary.
The policy notes that the FDA-cleared product INOmax is not approved for use in preterm infants (≤ 34 weeks) and that INOmax is contraindicated in infants who are dependent on right-to-left shunting. Providers should recognize that FDA labeling and device indications may influence coverage determinations for preterm infants and for infants with shunt-dependent physiology.
When INOmax (or other delivery systems) is used, medical records should document the indication consistent with FDA-cleared uses (term or near-term neonates ≥34 weeks with hypoxic respiratory failure or PPHN) and any off-label justification if applied to other populations.
This policy includes an operational reference instructing providers to consult the Idaho Medicaid Provider Handbook, General Information and Requirements for Providers: Non-Covered and Excluded Services for additional information about non-covered and excluded services. The handbook should be used alongside this medical policy when applying state-specific coverage rules.
Use of this policy must also align with any federal, state, or contractual benefit plan requirements that govern coverage determinations for Idaho members.
iNO treatment administered to individuals outside the Infancy age group (defined as birth through the first year of life) is considered experimental or investigational because FDA-approved indications are limited to neonatal use in term and near-term infants. Coverage for iNO beyond infancy is not supported by the indications outlined in this policy.
Providers seeking to use iNO outside infancy should document the clinical rationale and be aware that such use may not meet criteria for medical necessity under this policy.
Early routine, early rescue, or later rescue use of iNO for preterm infants born at 34 weeks gestation is not recommended and lacks consistent evidence of benefit. Systematic reviews and randomized controlled trials, including a Cochrane review of 17 RCTs, found no clear improvement in mortality or prevention of bronchopulmonary dysplasia and raised concerns about potential harms (for example, higher rates of severe intraventricular hemorrhage and signals for necrotizing enterocolitis).
Major guideline statements (including NIH and pediatric expert groups) therefore advise against routine or rescue use of iNO in preterm infants <34 weeks, and the balance of benefits and harms in this population remains unclear.
Applicable Codes and Clinical Thresholds
| 94799 | Unlisted pulmonary service or procedure |
Provider Actions, Authorization, and Documentation
Prior authorization implied for neonatal iNO (e.g., 94799)
Prior authorization is implied for inhaled nitric oxide (iNO) services billed (example code 94799) when used for the covered neonatal indications; documentation should demonstrate that coverage criteria are met (term/near-term infant ≥34 weeks with hypoxic respiratory failure or PPHN, absence of CDH, and failure of conventional treatments).
- Example reference code: 94799 (unlisted pulmonary service) — listing does not imply coverage
Document indication consistent with FDA-cleared uses
Document the clinical indication for iNO consistent with FDA-cleared uses — iNO is indicated for term and near-term neonates (>34 weeks gestation) with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension; off-label use in preterm infants or other indications should be justified in the medical record.
- Confirm gestational age ≥34 weeks if claiming the term/near-term indication
- Record clinical or echocardiographic evidence of pulmonary hypertension or PPHN
Prior authorization governed by benefit plan terms
Use this Medical Policy together with the applicable federal, state, or contractual benefit plan requirements and any third-party tools UnitedHealthcare may use (for example, InterQual); prior authorization and coverage follow the specific benefit plan terms.
- In the event of conflict, federal, state, or contractual benefit plan requirements govern coverage determinations
Document failure of conventional therapies before iNO
Demonstrate failure of conventional treatments (for example, mechanical ventilation and oxygenation strategies) before initiating iNO for covered neonatal hypoxic respiratory failure, except when iNO is used as bridge therapy postoperatively as described in guidelines.
- Document prior use of mechanical ventilation, oxygen, CPAP, or other conventional respiratory support and inadequate response
- If used postoperatively for pulmonary hypertension crises, document rationale as bridge therapy during acute recovery
Use iNO as initial therapy for postoperative PH crises per guidelines
For infants with postoperative pulmonary hypertension crises, follow guideline-based practice: AHA/ATS guidelines recommend iNO (and/or inhaled prostacyclin) as initial therapy for pulmonary hypertension crises in the postoperative setting as part of conventional postoperative care.
- Record that iNO is being used as initial therapy for a postoperative PH crisis per AHA/ATS guidance (Class I; Level of Evidence B)
- Document clinical context and that iNO is part of conventional postoperative management
Required clinical documentation for neonatal iNO requests
Include in the medical record gestational age at birth (to confirm ≥34 weeks for covered term/near-term indication), documentation that congenital diaphragmatic hernia (CDH) is absent when treating hypoxic respiratory failure/PPHN, evidence of failure of conventional treatments, and that the patient is within infancy.
- Gestational age at birth (weeks)
- Echocardiographic or clinical evidence of pulmonary hypertension/PPHN
- Statement that CDH is not present
- Documentation of prior conventional respiratory therapies and response
Reference FDA labeling and device clearances (INOmax, Noxivent, GeNOsyl)
When documenting device or product specifics, reference FDA labeling and clearances for INOmax, Noxivent, and the GeNOsyl MV-1000 delivery device, including indications and monitoring requirements as applicable to care.
- INOmax: indicated for term/near-term (>34 weeks) neonates with hypoxic respiratory failure and pulmonary hypertension; not approved for preterm infants (≤34 weeks)
- Noxivent and GeNOsyl MV-1000: FDA approvals/clearances for delivery systems and monitoring
Reference benefit plan requirements and Idaho Medicaid handbook
When determining coverage and documenting care, reference the applicable federal, state, or contractual benefit plan requirements and consult the Idaho Medicaid Provider Handbook for information on non-covered and excluded services.
- Check the member's specific benefit plan terms before relying on this Medical Policy
- Refer to the Idaho Medicaid Provider Handbook for non-covered/excluded services
Denial risk for non-covered indications (e.g., CDH, <34 weeks)
Claims for iNO that fall outside the covered indications may be denied as unproven, investigational, or not medically necessary; examples include newborns with congenital diaphragmatic hernia (CDH), preterm newborns <34 weeks gestation, or individuals outside the infancy age group.
- CDH and preterm infants <34 weeks are specifically listed as not medically necessary/unproven
- Services billed without documented covered indication risk denial
INOmax not approved for preterm infants; FDA contraindications apply
INOmax is not approved for use in preterm infants (≤34 weeks) and is contraindicated in infants known to be dependent on right-to-left shunting; FDA labeling should be considered when assessing coverage and contraindications.
- INOmax contraindicated in infants dependent on right-to-left shunting
- INOmax not approved for preterm infants (≤34 weeks)
Benefit plan requirements govern coverage determinations
Coverage determinations must follow the federal, state, or contractual benefit plan requirements; in the event of conflict, those requirements govern coverage decisions.
- Verify plan-specific terms prior to treatment authorization
- UnitedHealthcare may use third-party tools to assist in administering benefits
Background on Inhaled Nitric Oxide
Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator used to improve oxygenation in neonates with pulmonary hypertension. For term and near-term infants (≥34 weeks) 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) and is considered medically necessary when conventional therapies have failed.
iNO administration increases methemoglobin levels and requires appropriate delivery and monitoring systems (FDA-cleared delivery devices and gas analyzers). Use should follow accepted clinical practice, device labeling, and monitoring to mitigate potential adverse effects.
Definitions and Key Terms
Policy Revision History
Policy revised (CS173ID.B effective 2026-08-01): supporting information updated to reflect current clinical evidence and references; instruction added to refer to the Idaho Medicaid Provider Handbook for non-covered and excluded services; previous version CS173ID.A archived.
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