CurrentUnitedHealthcarePolicy CS173OH.C

Inhaled Nitric Oxide Therapy (for Ohio Only) – Community Plan Medical Policy

UnitedHealthcare Ohio-only medical policy CS173OH.C governing coverage of inhaled nitric oxide (iNO) therapy, defining medically necessary indications (term/near-term infants with hypoxic respiratory failure or PPHN), exclusions (congenital diaphragmatic hernia, preterm <34 weeks), and noting other investigational/experimental uses and FDA status. Applies to Ohio and refers to Ohio Administrative Code for evaluation of unproven or limited services.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for Ohio Only) – Community Plan Medical Policy

Policy CodePolicy CS173OH.C

Change TypeSupporting information updated (Description of Services, Clinical Evidence, References)

Effective DateDec 1, 2025

Next Review Date

Key ActionDocument gestational age (≥34 weeks), evidence of hypoxic respiratory failure or echocardiographic evidence of PPHN, absence of CDH, and failure of conventional treatments in the medical record to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Supporting Information: Updated Description of Service (12/01/2025).

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

1States applicable

Term/near-term ≥34wCovered Indication summary

Preterm <34wExcluded population

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CDHExcluded condition

References updatedRevision Note

Coverage Summary

Policy CS173OH.C (effective December 1, 2025) is an Ohio-only UnitedHealthcare coverage criteria document for Inhaled Nitric Oxide (iNO) therapy. The policy scope covers iNO for neonates and is specific to the state of Ohio.

Coverage stance: Mixed — iNO is designated medically necessary for term or near-term infants born at at least 34 weeks gestation with hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN) when conventional treatments have failed and congenital diaphragmatic hernia (CDH) is absent; it is covered as bridge therapy postoperatively for pulmonary hypertension in selected infants. iNO is not medically necessary / unproven for preterm newborns born at less than 34 weeks gestation, for newborns with CDH, and for individuals outside the infancy age group.

Covered population (brief): term/near-term infants (birth gestational age ≥ 34 weeks) with hypoxic respiratory failure or PPHN (without CDH) and after failure of conventional therapies. Excluded populations (brief): preterm infants born < 34 weeks and newborns with congenital diaphragmatic hernia (CDH).

Policy number: CS173OH.C; Subject: Inhaled Nitric Oxide Therapy (iNO) for neonates; Effective date: December 1, 2025.

Key facts and dates

States applicableOhio (state-specific policy applies)

Covered Indication summaryMedically necessary for term or near-term infants (gestational age ≥34 weeks) with hypoxic respiratory failure or echocardiographic evidence of PPHN; absence of congenital diaphragmatic hernia and failure of conventional treatments required

Excluded populationPreterm newborns born <34 weeks gestation (iNO unproven / not medically necessary)

Excluded conditionNewborns with congenital diaphragmatic hernia (CDH) — iNO not demonstrated to improve relevant outcomes and may cause harm

Revision NoteSupporting Information: Updated Description of Services, Clinical Evidence, and References sections (Summary of Changes = Supporting Information)

Effective dateDecember 1, 2025

Medical-Necessity Criteria

Medically Necessary Coverage for iNO

Covered when ALL of the following are met:

Medically Necessary Coverage for iNO - top level

Age group: Patient is an infant in the Infancy age group (birth through first year of life).
Reference definition of Infancy.
Gestational age at birth is at least 34 weeks (term or near-term).>=34 weeks
FDA indication for term and near-term neonates; policy specifies at least 34 weeks.
Diagnosis of hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN).

Provider Actions / Prior Authorization

Documentation Required

Document gestational age and diagnosis

Document in the medical record that the newborn meets gestational age and clinical criteria for iNO: gestational age at birth is at least 34 weeks; clinical evidence of hypoxic respiratory failure or echocardiographic evidence of persistent pulmonary hypertension of the newborn (PPHN); absence of congenital diaphragmatic hernia (CDH); and failure of conventional treatments (for example, mechanical ventilation).

Gestational age at birth (weeks) — confirm ≥ 34 weeks
Clinical diagnosis: hypoxic respiratory failure and/or echocardiographic evidence of PPHN
Documentation of absence of congenital diaphragmatic hernia (CDH)
Record of prior/conventional treatments tried and evidence of failure (e.g., mechanical ventilation, oxygen, CPAP, high-frequency ventilation)
Relevant imaging or echo reports supporting PPHN

Prior Authorization

Coding

Reference CPT code (unlisted pulmonary service)CPT

94799

Unlisted pulmonary service or procedure

Background & Evidence

Inhaled nitric oxide (iNO) is administered as a gas that selectively dilates pulmonary vessels in ventilated lung regions, lowering pulmonary vascular resistance to improve oxygenation. It is used in newborns with hypoxemic respiratory failure and persistent pulmonary hypertension of the newborn (PPHN) to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO).

The U.S. Food and Drug Administration has approved nitric oxide gas delivery systems (e.g., INOmax) for treatment of term and near-term neonates (> 34 weeks gestation) with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension; iNO is not approved for use in preterm infants (≤ 34 weeks).

Clinical rationale and evidence: randomized trials and meta-analyses demonstrate that iNO in term/near-term infants (≥ 34 weeks) with hypoxic respiratory failure or PPHN improves oxygenation and reduces the combined outcome of death or use of ECMO. By contrast, systematic reviews and trials in preterm infants (< 34 weeks) do not show consistent clinically significant benefit and raise potential safety concerns (for example, possible increased risk of severe intraventricular hemorrhage and other harms), so routine use in preterm newborns is not supported.

Evidence / Source	Key Finding
Wang et al. (2019) meta-analysis	Among infants >=34 weeks, iNO reduced the combined outcome of death or use of ECMO (relative risk reduction ~34%) and improved oxygenation; authors recommend iNO for respiratory failure in term/near-term infants.
Barrington et al. (2017a) Cochrane	High-quality evidence that iNO reduces death or use of ECMO in hypoxemic term and near-term infants without congenital diaphragmatic hernia (CDH); effective at initial concentration of 20 ppm.
Barrington et al. (2017b) Cochrane (preterm)	No clinically or statistically significant benefit of iNO in preterm infants (<34 weeks); meta-analysis suggested possible increased risk of grade 3/4 intraventricular hemorrhage (IVH).
INOmax FDA indication	INOmax 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; not approved for preterm infants (<=34 weeks); contraindicated in infants dependent on right-to-left shunting.
Key guideline references	Multiple professional guidelines (AHA/ATS, AAP, EPPVDN, NICE, NIH) support iNO for mechanically ventilated term/near-term infants with PPHN or hypoxemic respiratory failure (e.g., oxygenation index >25) and advise against routine use in preterm infants <34 weeks except for select situations; NICE/NIH/AAP recommend against routine preterm use.

Definitions

InfancyThe period from birth through the first year of life (Barfield 2016).

InterQual

Revision History

12/01/2025clarifiedLatest

Supporting Information: Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information. (Summary of Changes = Supporting Information)

12/01/2025revisedLatest

Archived previous policy version CS173OH.B.

Policy Summary

PayerUnitedHealthcare

PolicyInhaled Nitric Oxide Therapy (for Ohio Only) – Community Plan Medical Policy

Policy CodePolicy CS173OH.C

Change TypeSupporting information updated (Description of Services, Clinical Evidence, References)

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

Exclusion - CDH: Absence of congenital diaphragmatic hernia (CDH).

Evidence indicates lack of clear benefit for CDH; CDH listed as exclusion.

Conventional treatment failure: Failure of conventional treatments (e.g., mechanical ventilation).

Covered as Bridge Therapy

Covered as bridge therapy during acute recovery when ALL apply:

Covered as Bridge Therapy - top level

Postoperative use: Postoperative management of pulmonary hypertension associated with heart or lung surgery in infants.
Bridge therapy use: Used as bridge therapy during the acute recovery phase (practice-based guideline supported).
Evidence is inconclusive but practice-based guidelines support individual use as bridge therapy.

Not Medically Necessary / Unproven

iNO is unproven and not medically necessary for the following:

Not Medically Necessary / Unproven - top level

CDH: Newborns with congenital diaphragmatic hernia (CDH).
Systematic reviews suggest no clear benefit and possible harm in CDH.
Preterm <34 weeks: Preterm newborns who are less than 34 weeks gestation at birth.<34 weeks
Evidence fails to demonstrate clear benefit and suggests possible harms in preterm infants.
Outside infancy: Individuals outside of the Infancy age group (experimental or investigational due to lack of FDA-approved indications).
INOmax is approved for term and near-term neonates; use outside infancy is experimental/investigational.
Other indications not listed: Other newborns or indications not listed as medically necessary due to insufficient evidence of efficacy.

Ohio medical necessity evaluation

Requests for services that are stated as unproven or that are subject to coverage or quantity limits will be evaluated for medical necessity under Ohio Administrative Code 5160-1-01. Providers should follow applicable state and contract preauthorization and prior authorization processes when submitting requests for iNO services in Ohio.

Evaluate medical necessity per OAC 5160-1-01 and follow state/contract preauthorization procedures

Denial Risk

Denial risk for preterm infants and CDH

Claims for inhaled nitric oxide are at risk for denial when used in populations or indications that the policy identifies as not medically necessary or investigational. Specifically, iNO for newborns with congenital diaphragmatic hernia (CDH), preterm newborns born at less than 34 weeks gestation, or individuals outside the infancy age group are considered unproven or not medically necessary and may be denied.

Newborns with congenital diaphragmatic hernia (CDH)
Preterm newborns born at less than 34 weeks gestation
Individuals outside of the Infancy age group (beyond first year of life)

Documentation Required

Follow Federal/State/Contractual Requirements

When applying this policy, reference and follow any applicable federal, state (Ohio Administrative Code), or contractual requirements for benefit plan coverage. In the event of a conflict, federal, state (OAC), or contractual requirements govern over this policy.

Documentation Required

Use of InterQual

UnitedHealthcare uses InterQual as the primary source of medical/surgical criteria. If InterQual does not include applicable criteria for a request, UnitedHealthcare may apply its own Medical Policies, Coverage Determination Guidelines, and/or Utilization Review Guidelines that have been approved by the Ohio Department of Medicaid Services.

Proprietary criteria used by UnitedHealthcare for primary medical/surgical determinations; used for benefit administration and may be supplemented by UnitedHealthcare policies when InterQual lacks applicable criteria.

OACOhio Administrative Code (state regulations) that govern Medicaid medical necessity evaluations and may be referenced when evaluating unproven services or coverage limits (e.g., OAC 5160-1-01).