ModifiedCentenePolicy CP.MP.87

Therapeutic Utilization of Inhaled Nitric Oxide

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Defines medical necessity, continuation, and noncoverage criteria for initiation and continued use of inhaled nitric oxide in neonates, infants, children, and select adult indications (including COVID-19 severe ARDS) for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyTherapeutic Utilization of Inhaled Nitric Oxide

Policy CodePolicy CP.MP.87

Change TypeCriteria updates and threshold revisions

Effective Date

Next Review Date

Key ActionObtain prior authorization documenting gestational age, oxygen index (OI) values, evidence of pulmonary hypertension, iNO dosing and response; extended administration beyond 72 hours requires secondary medical director review.

SourceLink

POLICY UPDATE CHANGES

Updated oxygen index (OI) threshold in neonatal hypoxic respiratory failure criteria from >20 to 25.

Added indication for right ventricular failure as a perioperative indication for iNO.

Clarified continuation criteria and moved some items between sections (e.g., moved prior I.A.7 to continuation section).

Condensed criteria to note that initiation requests for premature infants <34 weeks GA may be reviewed case-by-case using criteria for ≥34 weeks.

Corrected prior revision entries regarding administration route and OI threshold; final OI threshold set to 25.

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ModifiedCentenePolicy CP.MP.87

Therapeutic Utilization of Inhaled Nitric Oxide

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Policy Summary

PayerCentene

PolicyTherapeutic Utilization of Inhaled Nitric Oxide

Policy CodePolicy CP.MP.87

Change TypeCriteria updates and threshold revisions

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Updated oxygen index (OI) threshold in neonatal hypoxic respiratory failure criteria from >20 to 25.

Added indication for right ventricular failure as a perioperative indication for iNO.

Clarified continuation criteria and moved some items between sections (e.g., moved prior I.A.7 to continuation section).

Condensed criteria to note that initiation requests for premature infants <34 weeks GA may be reviewed case-by-case using criteria for ≥34 weeks.

Corrected prior revision entries regarding administration route and OI threshold; final OI threshold set to 25.

Coverage Criteria for Inhaled Nitric Oxide (iNO)

Initial therapy — Neonatal hypoxic respiratory failure (≥34 weeks GA)

Covered when ALL of the following are met

Neonatal initiation criteria: 1) Newborn ≥ 34 weeks gestational age at birth; 2) Evidence of pulmonary arterial hypertension (either well-documented clinical evidence despite maximal respiratory support or echocardiogram suggestive of PAH); 3) Absence of unrepaired congenital diaphragmatic hernia (CDH), except when used as a bridge to surgical repair; 4) Failure of conventional therapies (mechanical ventilation, administration of high concentrations of oxygen [80–100%], high-frequency ventilation, induction of alkalosis, neuromuscular blockade and/or sedation); 5) Oxygen index (OI) > 25 (OI = mean airway pressure × FiO2 × 100 ÷ PaO2).OI > 25

From policy section I.A.

Initial therapy — Perioperative management in children and infants (≥34 weeks GA)

Covered when ALL of the following are met

Perioperative indications: 1) One of the following indications: (a) Congenital heart defect with iNO used in response to cardiac bypass surgery to repair a congenital heart defect that is causing PAH, perioperative stabilization and management of hypoxia, or right ventricular heart failure; OR (b) Pulmonary hypertensive crisis associated with heart or lung surgery (including immediate pre- or post-operatively for congenital diaphragmatic hernia). 2) Initiation of alternative vasodilator therapies (e.g., sildenafil or others) during iNO administration with the intent to wean or discontinue iNO (see continuation criteria).

From policy section I.B.

Initial therapy — COVID-19 severe ARDS

Covered when ALL of the following are met

COVID-19 severe ARDS indications: 1) Documented COVID-19 diagnosis with severe acute respiratory distress syndrome (ARDS); 2) Hypoxemia despite optimized ventilation and other rescue strategies; 3) iNO is being used as a rescue therapy and should be tapered off if no rapid improvement in oxygenation is observed.

From policy sections I.C and guideline summaries.

Continuation therapy

Covered when ALL of the following are met for members who previously met initial approval

Continuation response criteria: Member previously met initial approval criteria AND one of the following: A) Demonstrated clinical response during an iNO trial (recommended starting dose for term infants 20 ppm; trial may be increased up to 40 ppm) defined as PaO2 increase ≥20 mmHg or a 20% decrease in oxygen index (OI); OR B) Weaning protocol initiated after a 4–6 hour period of stability with inspired oxygen decreased to 60–80% or OI ≤10 and progressive dose reductions per protocol (e.g., 50% reductions at 4–6 hour intervals while OI ≤10, with slower wean once at 5 ppm).

Extended administration beyond 72 hours requires secondary medical director review (see revision notes).

Policy highlights and updated criteria notes

Policy criteria updated and condensed; notable guidance includes:

Premature infant policy note: Although the medical literature predominantly does not support routine use of iNO in premature infants <34 weeks gestational age at birth, requests for initiation in these infants may be reviewed on a case-by-case basis using consideration of the criteria for newborns ≥34 weeks in section I.

Case-by-case review requirement recorded in revision log

Oxygen index threshold: Oxygen index (OI) threshold used in neonatal criteria has been updated in revision history and is set to 25 for initiation criteria (I.A.6).OI = 25

OI threshold changed in revision history from >20 to 25.

Administration route: The prior requirement that iNO be administered via endotracheal tube or tracheostomy was removed (administrative correction).

Administrative change recorded in revision log

The policy identifies several indications for which inhaled nitric oxide (iNO) is not medically necessary. These include, but are not limited to: acute bronchiolitis, bronchopulmonary dysplasia (BPD), and congenital diaphragmatic hernia (CDH) except when used as a bridge to surgical repair. The policy also lists other exclusions such as routine treatment for acute respiratory distress syndrome (except where specifically covered), acute lung injury, treatment for adults with positive vaso-reactivity testing, routine post‑operative cardiac surgery use in adults, and use for vaso‑occlusive crises in members with sickle cell disease. Requests for iNO for these indications may be denied because safety and effectiveness have not been established.

This revision removed previously referenced ICD‑10 codes from the policy. The revision log documents that ICD‑10 code listings present in earlier versions were eliminated as part of an administrative update; explicit excluded diagnosis codes are not provided in the current document text.

Available evidence does not support routine or routine postoperative use of iNO in adults with ARDS. Clinical guideline panels recommend against routine iNO for mechanically ventilated adults with ARDS, and the policy states that evidence is insufficient to support broad use in critically ill adults (and children) with ARDS; reported benefits are generally limited to transient improvements in oxygenation without demonstrated mortality benefit and potential for harm (for example, renal impairment). Consequently, iNO is reserved as a targeted rescue therapy in selected cases (e.g., refractory hypoxemia) rather than for routine postoperative or routine ARDS management in adults.

The policy documents that the medical literature predominantly does not support routine initiation of iNO in premature infants <34 weeks gestational age. As a result, initiation in this population is generally not supported, but the policy allows that requests for infants <34 weeks may be reviewed on a case‑by‑case basis using the criteria applied to neonates ≥34 weeks when appropriate. This approach operationalizes individualized review rather than routine coverage for very preterm infants.

Coding and Thresholds

Referenced CPT CodesCPT

94799

Unlisted pulmonary service or procedure

HCPCSHCPCS

No codes listed

Coding adjustments notedmixed

No codes listed

Oxygen Index threshold for neonatal initiation (inv-13)

OI initiation threshold> 25

Applies toNeonates ≥ 34 weeks gestational age at birth meeting other initiation criteria

Source policy sectionI.A.6 (Oxygen index > 25)

Oxygen Index (OI) (inv-14)

OI numeric value referenced25

ContextFinalized OI value in revision log for initiation criteria I.A.6

Used in calculations as

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of inhaled nitric oxide (iNO) therapy. Requests must document that the member meets the clinical initiation criteria (e.g., neonatal hypoxic respiratory failure with oxygen index > 25 and evidence of pulmonary hypertension, perioperative indications such as post-cardiac bypass or pulmonary hypertensive crisis, or severe ARDS/COVID-19 with refractory hypoxemia) and, for continuation, demonstrate response to an iNO trial (e.g., PaO2 increase ≥ 20 mm Hg or 20% decrease in OI) or initiation of an established weaning protocol after stability. Extended administration beyond 72 hours requires secondary review by a medical director.

Affects initiation and continuation requests for iNO
Extended administration >72 hours requires medical director secondary review
Providers should include objective data (OI, PaO2 changes, echocardiogram findings, ventilatory support) when requesting authorization

Prior Authorization

Case-by-Case Review for Premature Infants < 34 Weeks GA

Requests for initiation of iNO in premature infants < 34 weeks gestational age at birth will be reviewed on a case-by-case basis. Such requests should reference the criteria for infants ≥ 34 weeks gestational age (including evidence of pulmonary hypertension, failure of conventional therapies, and oxygen index thresholds) and provide detailed clinical justification and supporting documentation to allow individualized medical necessity review.

Background

Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator used to improve pulmonary blood flow and oxygenation in specific clinical contexts. The policy notes that iNO can improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near‑term neonates with hypoxic respiratory failure when used according to criteria. It is also used as a rescue therapy for selected perioperative pulmonary hypertensive crises (including right ventricular failure in specified perioperative settings) and in selected cases of severe acute respiratory distress (including COVID‑19) when other optimized ventilation strategies and rescue measures have failed. The policy emphasizes that benefits in adults and preterm infants are limited and that evidence supports restricted, criteria‑based use rather than broad application.

Definitions and Clinical Thresholds

Oxygen Index (OI) definition (inv-24)

OI formulaMean airway pressure (cm H2O) × FiO2 × 100 ÷ PaO2 (mm Hg)

UnitsMean airway pressure in cm H2O; PaO2 in mm Hg; FiO2 as fraction (e.g., 0.21–1.0)

UseCalculated oxygen index used to quantify severity of hypoxemic respiratory failure in neonates

Positive response to iNO (inv-25)

Positive oxygenation responseIncrease in PaO2 ≥ 20 mmHg

Alternative response metric20% decrease in oxygen index (OI)

Timing