ModifiedUnitedHealthcarePolicy CS173NM.C

Inhaled Nitric Oxide Therapy (for New Mexico Only)

Medical policy governing coverage of inhaled nitric oxide (iNO) therapy for New Mexico UnitedHealthcare Community Plan members, specifying indications, exclusions, and supporting evidence primarily for neonatal populations.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for New Mexico Only)

Policy CodePolicy CS173NM.C

Change TypeClinical content and references revised

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting gestational age (≥34 weeks), diagnosis of hypoxic respiratory failure or PPHN, absence of CDH, and failure of conventional therapies.

SourceLink

POLICY UPDATE CHANGES

Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information.

≥34 wksgestational age threshold

≤34 wkspreterm not approved

20 ppminitial concentration

OI >25OI threshold

94799service code

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NMstate applicability

Coverage Criteria for Inhaled Nitric Oxide (iNO)

Covered: Term or Near-Term Infants with Hypoxic Respiratory Failure or PPHN

Covered when ALL of the following are met

Primary population: Infant who is term or near-term at birth (gestational age ≥ 34 weeks)>= 34 weeks

Document gestational age at birth

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

Exclusions: No congenital diaphragmatic hernia (CDH)

iNO not covered for newborns with CDH

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

Exception: covered as bridge therapy in postoperative pulmonary hypertension after heart or lung surgery

Not Covered / Experimental: Preterm and Non-Infant Populations

iNO is unproven, not medically necessary, or experimental when ANY of the following apply

Preterm newborns born less than 34 weeks gestation< 34 weeks

Evidence fails to demonstrate clear benefit and suggests possible harm

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

Excluded from covered indication; evidence does not show improved death/ECMO outcomes

Outside infancy or unapproved indications: Individuals outside the infancy age group or indications without FDA approval

Considered experimental/investigational

Term or near-term neonates with PPHN / PH crisis

iNO is indicated and supported for term/near-term neonates with PPHN and certain postoperative pediatric pulmonary hypertension scenarios when other criteria are met

Gestational age and diagnosis: Gestational age > 34 weeks AND clinical or echocardiographic evidence of pulmonary hypertension or PPHN causing hypoxemic respiratory failuregestational age >34 weeks

Supported by FDA indication and EPPVDN guidance

Severe oxygenation impairment or PH crisis: Severe hypoxemia (e.g., PaO2 < 100 mm Hg on 100% O2) or oxygenation index > 25, or postoperative pulmonary hypertension crisis despite conventional carePaO2 <100 mm Hg on 100% O2 or OI >25

EPPVDN and AHA/ATS guidance support iNO for these scenarios

Preterm infants (<34 weeks) — routine/rescue use

Not routinely covered or recommended for prevention of BPD or routine/rescue use in preterm infants

Preterm infant criteria: Infant born < 34 weeks gestation for whom iNO is being considered as routine or rescue therapy to prevent bronchopulmonary dysplasia (BPD) or to improve survival<34 weeks gestation

Multiple RCTs, systematic reviews, AAP and NIH guidance show no benefit and possible harm; routine or rescue use is not recommended

Congenital diaphragmatic hernia (CDH)

iNO may transiently improve oxygenation in congenital diaphragmatic hernia (CDH) but does not improve death or ECMO outcomes and may cause harm in subsets

CDH use considerations: Use of iNO in newborns with CDH may transiently improve oxygenation but randomized trials and systematic reviews show no benefit on death or need for ECMO; avoid or use with caution if significant left ventricular systolic dysfunction is present

Evidence suggests no net mortality/ECMO benefit and possible harm in subgroups; institutional practice should guide use

Postoperative pulmonary hypertension in infants/children

Individualized/bridge therapy may be appropriate

Postoperative PH management: Use as bridge therapy during acute postoperative recovery or as initial therapy for pulmonary hypertension crisis in infants/children in addition to conventional postoperative care

AHA/ATS recommend iNO and/or inhaled prostacyclin as initial therapy for PH crises; consider individualized clinical judgment

Inhaled nitric oxide (iNO) coverage specifically excludes newborns with congenital diaphragmatic hernia (CDH) and preterm newborns born at <34 weeks gestation; these populations are identified in the policy as not meeting the criteria for the covered neonatal indication. The policy also states that iNO therapy for individuals outside the infancy age group is considered experimental or investigational and therefore not covered under the standard criteria.

When evaluating requests for iNO, clinicians and reviewers should confirm that the infant does not have CDH, that gestational age meets the covered threshold, and that conventional treatments (for example, mechanical ventilation) were attempted and failed unless iNO is being used as bridge therapy after heart or lung surgery. Institutional practice and individual clinical circumstance may influence care for excluded diagnoses (for example CDH), but such use is outside the covered indication in this policy.

INOmax (nitric oxide gas delivery systems) is labeled by the FDA for use in term and near-term neonates born > 34 weeks gestation with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension. The policy emphasizes that INOmax is not approved for preterm infants (≤ 34 weeks) and notes that major expert bodies (for example, the NIH Consensus Statement and AAP guidance) do not recommend routine, early rescue, or later rescue iNO use in preterm infants <34 weeks who require respiratory support.

Because FDA labeling and guideline recommendations do not support iNO for preterm infants, requests for INOmax in that population may be inconsistent with the device/drug labeling and are associated with higher coverage risk unless supported by plan-specific exception language or compelling clinical justification.

Coverage under this policy is subject to the member’s federal, state, or contractual benefit plan terms. In the event plan-specific requirements differ from this Medical Policy, the federal, state, or contractual requirements govern and may create additional exclusions or authorization requirements.

Before initiating or authorizing iNO, verify the member’s benefit plan rules and any applicable prior authorization requirements; UnitedHealthcare may also use third-party tools (for example, InterQual) to assist with benefit administration.

In summary, the policy identifies the following populations as non-covered, investigational, or not medically necessary under the standard criteria: newborns with congenital diaphragmatic hernia (CDH), preterm newborns born <34 weeks gestation, and individuals outside the infancy age group. These determinations reflect the available evidence and FDA indications.

Requests for iNO outside the covered term/near-term neonatal indication should be evaluated as experimental/investigational or not medically necessary unless a specific plan or contractual provision explicitly authorizes otherwise.

Systematic reviews and randomized controlled trials have not demonstrated consistent benefit of iNO for preterm infants born 34 weeks gestation. A Cochrane review of 17 randomized trials found no clinically meaningful effect on mortality or prevention of bronchopulmonary dysplasia (BPD) and suggested a possible increased risk of severe intraventricular hemorrhage (grade 3–4).

Additional meta-analyses and systematic reviews (for example, Zheng et al., 2023) reported no clear consistent improvement in major outcomes and raised safety concerns (for example, an increased risk of necrotizing enterocolitis in some analyses). Major guideline statements (NIH consensus and the AAP Committee on Fetus and Newborn) do not recommend routine or rescue iNO use in preterm infants <34 weeks because the balance of benefits and harms is unclear.

Coding and Clinical Thresholds

Applicable CPT CodesCPT

94799

Unlisted pulmonary service or procedure

Device and product identifiers referencedmixed

INOmax	Brand name nitric oxide gas delivery system (FDA-cleared drug/device)
INOvent / INOmax DS / INOmax DSIR	FDA-cleared delivery systems for administering iNO with monitoring
Noxivent	FDA-approved nitric oxide delivery system (approved Oct 2, 2018)
GeNOsyl MV-1000	510(k)-cleared nitric oxide delivery device (2012)

Oxygenation Index (OI)

Oxygenation Index (OI) thresholdConsider iNO when oxygenation index exceeds 25

Alternate oxygenation criterion from EPPVDNPaO2 < 100 mm Hg on 100% oxygen may also indicate iNO use

Evidence basisAHA/ATS guideline cites multiple randomized trials/meta-analyses supporting OI > 25 as Class I indication

Initial iNO concentration used in trials

Initial trial concentration20 ppm (initial concentration shown effective in term/near-term trials)

Dose-reduction schema in some preterm RCTsExample: 20 ppm reduced to 10 ppm at 72–96 hours then to 5 ppm by day 10–11

Prior Authorization, Documentation, and Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required for inhaled nitric oxide (iNO) when used for neonatal/infant indications. Submit a prior authorization request before initiating iNO except in emergent bridge therapy scenarios (see step/sequence callout).

Affected service: inhaled nitric oxide (iNO) therapy
Typical procedure code referenced: CPT 94799

Documentation Required

Authorization Documentation — Key Elements

Authorization requests must include clear documentation of gestational age at birth, a diagnosis supporting pulmonary hypertension or PPHN, and the clinical rationale for iNO (including failure of conventional therapies when applicable).

Minimum documentation: gestational age (weeks), primary diagnosis, echocardiography results or other objective evidence of pulmonary hypertension/PPHN

Background and Rationale

Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator that relaxes vascular smooth muscle in ventilated lung units, lowering pulmonary vascular resistance and improving ventilation–perfusion matching. In neonates with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn (PPHN), iNO can improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) when used in the appropriately selected term or near-term infant.

iNO administration increases methemoglobin levels and requires delivery systems that measure nitric oxide and nitrogen dioxide concentrations; FDA-cleared delivery systems (for example, INOmax and other named devices) include monitoring components. The physiologic effects and the potential for harm in some populations (for example, preterm infants and those with CDH or left ventricular dysfunction) underlie the policy’s selective coverage stance favoring term/near-term neonates with documented PPHN or refractory hypoxemia.

Definitions

Infancy — definition

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

ReferenceBarfield 2016 as cited in policy

Scope noteFederal, state, or contractual definitions supersede this definition if provided

PPHN — definition

DefinitionPersistent pulmonary hypertension of the newborn (PPHN): clinical or echocardiographic evidence of elevated pulmonary vascular resistance causing hypoxemia

Indication contextPPHN in term/near-term mechanically ventilated infants is an accepted indication for iNO to improve oxygenation and reduce ECMO need

Diagnostic criteria referenced

Policy Revision History

2025-11-01policy_revisionLatest

Updated Description of Services, Clinical Evidence, and References sections to reflect current information; archived prior version CS173NM.B.

2025-11-01archived_previous_versionLatest

Prior policy version CS173NM.B was archived when CS173NM.C was issued.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for New Mexico Only)

Policy CodePolicy CS173NM.C

Change TypeClinical content and references revised

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting gestational age (≥34 weeks), diagnosis of hypoxic respiratory failure or PPHN, absence of CDH, and failure of conventional therapies.

SourceLink

On This Page

Evidence sourceCochrane review and randomized trials report efficacy at 20 ppm for term/near-term infants

Gestational age for FDA indication

FDA gestational age indication for INOmax> 34 weeks (term and near-term neonates)

Regulatory limitationINOmax is not approved for use in preterm infants (≤ 34 weeks)

Clinical corroborationEPPVDN supports use in neonates >34 weeks with PPHN or severe hypoxemia

Clinical notes describing prior conventional therapies tried (e.g., oxygen, CPAP, mechanical ventilation, surfactant) and response

Note

Check Plan-Specific and Regulatory Requirements

Verify federal, state, and contract-specific benefit plan requirements and any plan-level preauthorization rules before submitting an authorization to UnitedHealthcare. Coverage determination is governed by the member's plan terms and applicable laws; in a conflict, federal/state/contractual requirements override this policy.

Confirm plan benefits, exclusions, and any prior authorization portals or forms required by the member's contract
If plan requires use of third-party criteria (e.g., InterQual®), follow that process

Denial Risk

Non‑Covered or Not Medically Necessary Indications

iNO is considered non-covered or not medically necessary for indications outside the term/near-term neonatal population and for certain conditions with insufficient evidence. Do not authorize iNO for these indications absent compelling supporting documentation and applicable plan exceptions.

Not covered / not medically necessary: treatment of newborns with congenital diaphragmatic hernia (CDH)
Not covered / not medically necessary: preterm newborns born at less than 34 weeks gestation
Experimental/investigational for individuals outside infancy age group

Note

FDA Labeling and Coverage Risk

INOmax and related delivery systems are FDA‑cleared for term and near‑term neonates (>34 weeks gestation) with hypoxic respiratory failure and clinical/echocardiographic evidence of pulmonary hypertension. INOmax is not approved for use in preterm infants (≤34 weeks), and use in that population may conflict with FDA labeling and pose coverage risk.

INOmax indication: term and near‑term (>34 weeks) neonates with hypoxic respiratory failure and evidence of pulmonary hypertension/PPHN
INOmax NOT approved for preterm infants (≤34 weeks) — document rationale if treating outside labeling

Note

Coverage Governed by Plan‑Specific Requirements

Coverage decisions must reference the member's federal/state/contractual benefit plan. UnitedHealthcare may apply additional utilization management tools or third‑party criteria when evaluating requests.

In event of conflict, plan or statutory requirements govern coverage
UnitedHealthcare may use tools (e.g., InterQual®) to assist determinations

Documentation Required

Required Clinical Documentation

Required clinical documentation to support authorization includes objective and contextual information demonstrating medical necessity for neonatal iNO.

Gestational age at birth (weeks) — must be ≥34 weeks for routine coverage
Primary diagnosis and indication for iNO (e.g., hypoxic respiratory failure, PPHN)
Echocardiography report or other objective evidence of pulmonary hypertension/PPHN
Clinical course and response to conventional therapies (oxygenation measures, ventilator settings, oxygenation index or PaO2 where available)
Reason for use if postoperative bridge therapy following heart or lung surgery

Step Therapy

Step Therapy and Sequence Considerations

Step/sequence considerations: iNO is generally reserved after failure of conventional treatments in term/near‑term infants. An exception is short‑term bridge therapy in the immediate postoperative period for pulmonary hypertension crises or post‑surgical recovery.

Prerequisite: inadequate response to conventional measures (oxygen, CPAP, conventional or high‑frequency ventilation, surfactant where appropriate) before initiating iNO in routine PPHN management
Exception: postoperative PH crises or acute postoperative recovery — iNO (or inhaled prostacyclin) may be authorized as bridge therapy per clinical judgment and relevant guidelines (AHA/ATS)
Consider alternative inhaled vasodilators (e.g., inhaled prostacyclin) per guideline recommendations and availability

Billing Rule

Check Plan‑Specific Limits and Billing Requirements

Before proceeding with authorization or administration, verify any additional plan limits, quantity thresholds, or exclusion criteria that may apply to the member's benefit plan.

Confirm billing and coding guidance (e.g., CPT 94799) and any plan-specific billing instructions
Check for member‑specific exclusions, annual limits, or prior authorization conditions

EPPVDN: PaO2 <100 mm Hg on 100% O2 or oxygenation index >25 as thresholds for treatment consideration

Early rescue iNO — definition and trial outcomes (preterm infants)

DefinitionEarly rescue iNO: administration of inhaled nitric oxide within the first three days of life for oxygenation defects in preterm infants

Trial outcome summaryMultiple RCTs and meta-analyses (including Barrington et al. Cochrane review) found no significant effect on mortality or prevention of BPD for early rescue iNO in preterm infants

Safety signalMeta-analysis suggested possible increased risk of severe intraventricular hemorrhage (grade 3–4) with iNO in some preterm studies

iNO — abbreviation and context

AbbreviationiNO = inhaled nitric oxide

Therapeutic effectInhaled gas that dilates pulmonary vessels in ventilated lung regions to reduce pulmonary vascular resistance

Clinical use noteUsed to improve oxygenation and reduce ECMO need in term/near-term neonates with PPHN; risks and lack of benefit noted in preterm populations