ModifiedUnitedHealthcarePolicy CS173KY.08

Inhaled Nitric Oxide Therapy (for Kentucky Only)

This policy governs coverage of inhaled nitric oxide therapy in Kentucky, primarily addressing use in term and near-term infants with hypoxic respiratory failure or PPHN and specifying exclusions for preterm infants and other populations.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for Kentucky Only)

Policy CodePolicy CS173KY.08

Change TypeRevised clinical evidence & referencesarchived prior version

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document gestational age (≥34 weeks), absence of CDH, failure of conventional therapy, and evidence of pulmonary hypertension.

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 excluded

94799reference procedure code

POI: bridge therapypostoperative bridge

1prior versions archived

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Kentuckyjurisdiction

Coverage Criteria for Inhaled Nitric Oxide (iNO)

Initial therapy — Term/Near-term infants

Covered when ALL of the following are met

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

CDH patients are evaluated separately; evidence does not demonstrate benefit and may suggest harm

Failure of conventional treatments: Failure of conventional supportive measures such as mechanical ventilation and oxygenation strategiesfailure of conventional therapy

iNO is used after conventional measures; intended to improve oxygenation and reduce need for ECMO

Postoperative bridge therapy

Covered when ALL of the following are met

Postoperative pulmonary hypertension in infants: Use for postoperative management of pulmonary hypertension associated with heart or lung surgery in infants as bridge therapy during the acute recovery phasepostoperative acute phase

Clinically accepted option; AHA/ATS guidance supports iNO (and/or inhaled prostacyclin) as initial therapy for postoperative PH crises

Not Medically Necessary / Experimental

Not covered / considered unproven or investigational for the following

Excluded newborn populations: Newborns with congenital diaphragmatic hernia (CDH) or preterm newborns <34 weeks gestationCDH present OR gestational age <34 weeks

Systematic reviews and trials do not show consistent benefit and may indicate harm (e.g., IVH, NEC); routine coverage is not supported

Individuals outside infancy: Individuals outside the infancy age group for indications without FDA approvalage >1 year

Use outside infancy is experimental/investigational due to lack of FDA-approved indications

Coverage criteria by clinical scenario

Coverage is supported when clinical evidence and guideline recommendations align with FDA indications or specific high-risk scenarios; coverage is restricted where evidence shows lack of benefit or potential harm.

FDA-indicated neonatal PPHN (term/near-term): iNO for term and near-term neonates (>34 weeks gestation) with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension is indicated to improve oxygenation and reduce need for ECMO.gestational age >34 weeks; PaO2 <100 on 100% O2 or oxygenation index >25 as per EPPVDN

Supported by FDA indication, EPPVDN criteria, and AHA/ATS guideline recommending use for OI >25; meta-analyses show reduced death or ECMO

Preterm African American subgroup: Post-hoc subgroup analyses suggest a possible reduction in death or BPD composite for African American preterm infants in select trials, but these findings are hypothesis-generating and insufficient alone to support routine coverage.post-hoc subgroup evidence

Consider individual case review if compelling documentation, but not routine coverage

Use of inhaled nitric oxide (iNO) in newborns with congenital diaphragmatic hernia (CDH) and in preterm newborns less than 34 weeks gestation is considered unproven or not medically necessary. The policy specifies that iNO is indicated and proven for term or near-term infants (≥34 weeks gestation) with hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN) only when there is absence of CDH and after failure of conventional treatments (for example, mechanical ventilation). For CDH specifically, available trials and reviews do not demonstrate consistent benefit for death or ECMO avoidance and raise concerns about potential harm, therefore routine use in CDH is not supported and should be individualized with caution.

The INOmax® delivery system is FDA-cleared for treatment of term and near-term neonates (>34 weeks gestation) with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension; INOmax is not approved for use in preterm infants (≤34 weeks). In addition, the National Institute for Health and Care Excellence (NICE) recommends: do not routinely use inhaled nitric oxide for preterm babies who need respiratory support for RDS, unless other specific indications such as pulmonary hypoplasia or pulmonary hypertension are present—use in those scenarios is off-label.

When applying this policy, coverage determinations must conform to applicable federal, state, or contractual benefit plan requirements. If those requirements conflict with this policy, the federal, state, or contractual terms govern the determination. Providers should check the relevant benefit terms and any Kentucky-specific approvals or modifications before relying on this policy for coverage decisions.

Excluded and unproven uses reiterated by this policy include: iNO for newborns with congenital diaphragmatic hernia (CDH) and for preterm newborns born at less than 34 weeks gestation. Routine, early rescue, or later rescue administration of iNO in preterm infants for prevention of bronchopulmonary dysplasia (BPD) or to improve survival has not shown consistent benefit and may be associated with harm (for example, higher-grade intraventricular hemorrhage), so such uses are considered not medically necessary for routine coverage.

Systematic reviews and randomized trials in preterm infants (including a Cochrane review identifying 17 randomized controlled trials) have not demonstrated a clear benefit of iNO for survival or prevention of BPD in infants born <34 weeks. Meta-analyses and large RCTs found no significant reductions in death or BPD with early or routine iNO use and raised safety concerns such as a possible increased risk of grade 3–4 intraventricular hemorrhage and other morbidities. Consensus statements (NIH, AAP) and guideline reviews therefore do not recommend routine use of iNO for preterm infants less than 34 weeks gestation and advise against early routine or rescue strategies for BPD prevention.

Coding and Billing References

Applicable CPT Codes (reference)CPT

94799

Unlisted pulmonary service or procedure.

Affected Codes (see policy and InterQual)mixed

affected codes

Placeholder reference to codes affected by prior authorization and coverage (document refers to InterQual and payer guidelines for exact codes).

Gestational age threshold — key facts

Gestational age thresholdTerm or near-term defined as ≥ 34 weeks gestation at birth

Excluded gestational agesPreterm newborns < 34 weeks gestation are considered not covered / not medically necessary

FDA-indicated cutoffINOmax indicated for neonates > 34 weeks (FDA information)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Coding

Prior authorization is required for inhaled nitric oxide (iNO) therapy. Providers should obtain authorization before initiating iNO for covered indications; use CPT 94799 (Unlisted pulmonary service or procedure) for billing when a specific CPT code for iNO service is not available and include clinical justification with the request.

Prior authorization required for iNO services
Bill using CPT 94799 when applicable; include clinical justification
Authorization requests should reference InterQual criteria and this policy

Prior Authorization

Prior Authorization for FDA-Indicated Use

Authorization requests for iNO should reflect the FDA-indicated population: term or near-term neonates (> 34 weeks gestation at birth) with hypoxic respiratory failure and clinical or echocardiographic evidence of pulmonary hypertension. Requests for preterm infants (≤ 34 weeks), infants with congenital diaphragmatic hernia (CDH), or use outside infancy should include robust supporting evidence; such uses are frequently considered unproven, not medically necessary, or experimental.

Background

Nitric oxide administered by inhalation produces selective pulmonary vasodilation by relaxing pulmonary vascular smooth muscle, thereby reducing pulmonary vascular resistance and improving pulmonary blood flow and oxygenation. This mechanism underlies its clinical use to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term infants with hypoxic respiratory failure or persistent pulmonary hypertension of the newborn (PPHN). iNO therapy increases methemoglobin levels and requires a complete delivery system with gas analyzers as specified by the FDA; benefits and harms vary by population, with demonstrated benefit in term/near-term neonates but inconsistent evidence and potential harms in preterm infants.

Key Definitions

Infancy — definition

DefinitionInfancy: the period from birth through the first year of life (Barfield 2016)

Policy scope noteCoverage statements and exclusions in this policy apply to patients within the infancy period unless otherwise specified

Age boundary for coverage languageIndividuals older than 1 year are considered outside the infancy group and uses without FDA indication are treated as experimental/investigational

Term and near-term neonates — definition and FDA-indicated population

Term and near-term definitionInfants > 34 weeks gestation (term or near-term)

Regulatory contextINOmax is indicated for treatment of term and near-term (> 34 weeks) neonates with hypoxic respiratory failure and is not approved for preterm infants (≤ 34 weeks)

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for Kentucky Only)

Policy CodePolicy CS173KY.08

Change TypeRevised clinical evidence & referencesarchived prior version

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document gestational age (≥34 weeks), absence of CDH, failure of conventional therapy, and evidence of pulmonary hypertension.

SourceLink

On This Page

Congenital diaphragmatic hernia (CDH): iNO may transiently improve oxygenation in CDH but trials and meta-analyses do not show benefit for death or ECMO use and may suggest harm; routine use is not recommended and should be individualized with caution, particularly if left ventricular dysfunction is present.presence of CDH

Systematic reviews and observational data indicate lack of net benefit; avoid routine use

Postoperative pulmonary hypertension in CHD: Evidence is inconclusive for routine postoperative iNO benefit in congenital heart disease-associated PH, but practice-based guidance supports short-term bridge therapy for acute PH crises and right heart failure; consider use with close monitoring in acute postoperative PH crises.postoperative PH crisis

AHA/ATS recommends iNO and/or inhaled prostacyclin as initial therapy for PH crises; use as bridge therapy may be covered

Authorizations should match FDA-indicated use: neonates >34 weeks with hypoxic respiratory failure and PPHN evidence
Use in preterm infants (≤34 weeks) or with CDH is generally not covered and may be denied
Out-of-age-group use (beyond infancy) is considered experimental/investigational

Documentation Required

Prior Authorization Requirement and Review Sources

Prior authorization decisions will incorporate InterQual criteria as the primary clinical review tool; where InterQual is not applicable, reviewers will use UnitedHealthcare Medical Policies, Coverage Determination Guidelines, and Utilization Review Guidelines. Always verify and follow any applicable federal, state, or contractual requirements that may supersede standard policy rules.

Use InterQual as the main review criteria for authorization
If InterQual lacks applicable criteria, apply UnitedHealthcare policies/guidelines
Federal, state, or contractual requirements override this policy when in conflict

Step Therapy

Step Therapy Expectations and Postoperative Use

Step therapy: iNO is expected to be used after failure of conventional treatments in term or near-term infants (≥ 34 weeks gestation) with hypoxic respiratory failure (e.g., oxygen, CPAP, conventional or high-frequency ventilation). For postoperative pulmonary hypertension crises, guidelines recommend initiation of iNO (or inhaled prostacyclin) as initial therapy in addition to conventional care.

iNO generally authorized after documented failure of conventional respiratory support in neonates ≥34 weeks
For postoperative PH crises, iNO (or inhaled prostacyclin) may be used as initial therapy per AHA/ATS guidance

Documentation Required

Required Clinical Documentation

Clinical documentation must be provided with authorization requests to demonstrate medical necessity for iNO. Required elements include evidence of gestational age, absence of congenital diaphragmatic hernia (CDH) when applicable, documentation of failure of conventional therapy, and clinical or echocardiographic evidence of pulmonary hypertension or indication (e.g., PPHN).

Document gestational age at birth (must be ≥ 34 weeks for standard coverage)
Document absence of CDH if claiming eligibility (CDH is an exclusion)
Document failure of conventional treatments (oxygen, ventilation, surfactant as applicable)
Provide clinical and/or echocardiographic evidence of pulmonary hypertension or PPHN

Documentation Required

Documentation and Criteria Sources

Include references to the sources used to evaluate the request: InterQual criteria (primary), UnitedHealthcare Medical Policies/Coverage Determination Guidelines/Utilization Review Guidelines (secondary), and relevant guideline or FDA documentation as needed. Cite evidence when requesting coverage for uses outside standard indications.

Authorization packages should reference InterQual criteria and specify which criteria are being met
When requesting coverage for out-of-indication use, include supporting literature, guideline statements, or rationale
Regulatory and guideline sources (FDA, EPPVDN, AHA/ATS) may be cited to support clinical rationale

Denial Risk

Denial Triggers and Noncovered Uses

Denial triggers and coverage limits: iNO use in newborns < 34 weeks gestation, infants with CDH, and use outside infancy or without FDA indication are common reasons for denial as not medically necessary or experimental/investigational. Providers should anticipate requests for additional information when clinical circumstances deviate from standard indications.

Likely denial for neonates <34 weeks or those with CDH
Use outside infancy or without FDA indication may be denied as experimental/investigational
Provide robust justification and evidence for atypical cases to avoid denial

Note

Benefit Requirement Conflicts

Benefit plan conflicts: always verify federal, state, or specific contractual benefit requirements before relying on this policy. When there is a conflict between this policy and applicable law or contract terms, the federal/state/contract terms govern coverage decisions.

Check member's plan documents and applicable regulations prior to authorization
In conflicts, federal/state/contractual requirements override this policy

Prior Authorization

Provider Action for Atypical or Out-of-Indication Requests

Provider action: when clinical scenarios do not match standard indications (for example, preterm infants, CDH, or older children/adults), include detailed clinical rationale, prior attempted therapies, imaging/echo reports, and peer-reviewed evidence when requesting coverage. UnitedHealthcare may apply InterQual and policy-informed review and may request additional information or peer-to-peer discussion.

Submit full clinical record, echo reports, ventilation/oxygenation indices, and prior treatment details for atypical cases
Be prepared for additional information requests or peer-to-peer review

Clinical implicationThis population is the FDA-indicated group and is where demonstrated therapeutic benefit for PPHN is established

Early rescue use — definition from trials

Early rescue use — trial definitionAdministration of iNO over the first three days of life for defects in oxygenation in preterm infants (as defined in grouped RCTs)

Trial groupingCochrane review divided preterm trials into early rescue (first 3 days), routine treatment, and later treatment (>3 days)

Outcome contextEarly rescue trials showed no significant effect on mortality or BPD and suggested possible increased risk of severe IVH

Key literature and guideline sources

Key evidence and guideline sourcesHayes Directory review (Hayes, Inc.) — systematic evidence summaries and reviews

AAP guidanceAmerican Academy of Pediatrics statement on use of iNO in preterm infants (Pediatrics 2014)

NICE guidelineNICE guideline NG124: Specialist neonatal respiratory care for babies born preterm

FDA labeling and device infoINOmax FDA clearance and indication documents describing use in neonates >34 weeks and device system requirements

Randomized and systematic reviewsCochrane review (Barrington et al. 2017b) analyzing 17 RCTs of iNO in preterm infants and other RCTs/observational studies addressing CDH and PPHN