CurrentCareSource GeorgiaPolicy Inhaled Nitric Oxide-MP-MM-1321

Inhaled Nitric Oxide (iNO) coverage criteria

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Clinical coverage policy for initiation, appropriate uses, limitations, and non-covered indications for inhaled nitric oxide (iNO) therapy for CareSource Marketplace members (applies to listed markets).

Policy Summary

PayerCareSource Georgia

PolicyInhaled Nitric Oxide (iNO) coverage criteria

Policy CodePolicy Inhaled Nitric Oxide-MP-MM-1321

Change TypeNo material change

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionDocument that conventional therapies have failed or are expected to fail and provide objective evidence of PPHN when requesting initiation of iNO for near‑term/term infants.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥34wgestational age threshold

3 daysduration review threshold

13not medically necessary items

1999FDA approval year

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CurrentCareSource GeorgiaPolicy Inhaled Nitric Oxide-MP-MM-1321

Inhaled Nitric Oxide (iNO) coverage criteria

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Policy Summary

PayerCareSource Georgia

PolicyInhaled Nitric Oxide (iNO) coverage criteria

Policy CodePolicy Inhaled Nitric Oxide-MP-MM-1321

Change TypeNo material change

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionDocument that conventional therapies have failed or are expected to fail and provide objective evidence of PPHN when requesting initiation of iNO for near‑term/term infants.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥34wgestational age threshold

3 daysduration review threshold

13not medically necessary items

1999FDA approval year

Coverage Criteria for Inhaled Nitric Oxide (iNO)

Initiation — Near-term and Term Infants (medically necessary)

Covered when ALL of the following are met:

Gestational age: Infant is near-term or term (>= 34 weeks corrected gestational age)>=34 weeks

Conventional therapies (mechanical ventilation, administration of high concentrations of oxygen [80-100%], high frequency oscillatory ventilation [HFOV], induction of respiratory alkalosis, neuromuscular blockade, and sedation) have failed or are expected to fail

Step therapy requirement

Cardiac contraindication: Absence of ductal-dependent congenital heart disease

Evidence of PPHN: Evidence of persistent pulmonary hypertension of the newborn (echocardiographic findings, right heart catheterization, or abnormal oxygen index/arterial blood gases not related to another condition)

Medically appropriate uses (other)

Use of iNO is considered medically appropriate for any of the following clinical conditions:

Postoperative neonates with CHD: Postoperative management of neonates >= 34 weeks corrected gestational age after repair of congenital heart disease with evidence of pulmonary hypertension

Post-op pediatric heart or lung surgery: Postoperative management following pediatric heart or lung surgery with evidence of pulmonary hypertension

Pulmonary vasoreactivity testing: Management of pulmonary hypertension during a heart catheterization to determine pulmonary vasoreactivity

BPD-related PH crisis: Management of bronchopulmonary dysplasia related pulmonary hypertension during acute crisis (transition to enteral therapy when acute crisis improves)

Continuation criteria

Continued iNO beyond initial period:

Review after 3 days: iNO therapy for more than 3 days is subject to medical necessity review with medical record documentation to support continued use>3 days

Consider discontinuation if there is lack of positive response or inability to wean oxygen and/or iNO

The policy identifies a list of conditions for which inhaled nitric oxide (iNO) is considered not medically necessary. These explicitly listed exclusions include: congenital diaphragmatic hernia; acute bronchiolitis; bronchopulmonary dysplasia (BPD); acute pulmonary embolism; acute respiratory distress syndrome (ARDS); acute lung injury; lung transplantation; liver transplantation; pulmonary fibrosis; hemorrhagic shock; pneumonectomy post trauma; cystic fibrosis; and malaria. Use of iNO for these indications will be considered not medically necessary and may be denied.

Sections labeled Policy and Conditions of Coverage in the provided document are marked NA (not applicable). This means no additional procedural or coverage-condition text is provided in those sections; it does not override or remove the explicit exclusions and medical-necessity criteria stated elsewhere in the policy.

The policy explicitly identifies the following as not medically necessary uses of iNO: congenital diaphragmatic hernia; acute bronchiolitis; bronchopulmonary dysplasia (BPD); acute pulmonary embolism; acute respiratory distress syndrome (ARDS); acute lung injury; lung transplantation; liver transplantation; pulmonary fibrosis; hemorrhagic shock; pneumonectomy post trauma; cystic fibrosis; and malaria.

Within the supplied document excerpts, there are sections marked NA and no additional explicit text stating other conditions are not medically necessary. In other words, beyond the exclusions listed in the main policy text, the provided 'NA' sections do not contain further 'not medically necessary' statements.

Key Clinical Thresholds and Coding-Adjacent Metrics

Corrected gestational age threshold

Corrected gestational age threshold>= 34 weeks corrected gestational age (nearterm/term infants) — initiation eligible when >=34 weeks

Example use in criteriaApplies to initiation of iNO for hypoxic respiratory failure or PPHN when all other criteria met

Source contextPolicy states initiation is medically necessary for nearterm (≥ 34 weeks corrected gestational age) and term infants

Duration review threshold

Duration review threshold> 3 days — iNO therapy >3 days is subject to medical necessity review and requires documentation

Documentation requirementMedical record must support continued use beyond 3 days, including evidence of positive response and ability to wean oxygen and/or iNO

Provider Requirements, Prior Authorization, and Denial Triggers

Prior Authorization

Prior authorization / documentation required for initiation in near‑term/term infants

Initiation of iNO for near‑term (≥34 weeks corrected gestational age) and term infants with hypoxic respiratory failure or persistent pulmonary hypertension requires documentation that conventional therapies have failed or are expected to fail, absence of ductal‑dependent congenital heart disease, and objective evidence of PPHN (echocardiography, right heart catheterization, or abnormal oxygen index/ABGs not attributable to another condition).

Note

No prior authorization specified in these sections

No prior authorization requirements are specified in the provided sections of the document.

Step Therapy

Step therapy — trial of conventional therapies required before iNO

Background on Inhaled Nitric Oxide

Inhaled nitric oxide (iNO) is described as a selective pulmonary vasodilator used to improve oxygenation by dilating pulmonary vasculature in ventilated regions of the lung. The policy notes its primary clinical role is for nearterm and term infants (≥34 weeks corrected gestational age) with hypoxic respiratory failure or evidence of persistent pulmonary hypertension of the newborn (PPHN). The document also references that evidence does not support routine use in preterm infants (<34 weeks) or for many older pediatric/adult indications such as ARDS, where benefits on mortality have not been demonstrated and potential harms have been reported.

Definitions and Clinical Terms

Bronchopulmonary dysplasia (BPD)

DefinitionChronic lung disease that generally occurs due to multiple factors in premature infants.

Clinical relevanceListed as a condition for which iNO is not medically necessary; BPD-related pulmonary hypertension may be managed in acute crisis as specified elsewhere

Typical populationPremature infants with prior respiratory support and lung injury

Corrected Gestational Age

DefinitionCorrected Gestational Age = gestational age at birth + postnatal age in weeks (e.g., 24 weeks GA at birth + 10 weeks old = 34 weeks corrected GA)

Use in policyUsed to determine eligibility for iNO initiation (nearterm/term defined by corrected GA >=34 weeks)

References and Revision History

2021-03-17policy_created

Policy created (new policy).

2022-05-11revision

Updated definitions and D. IV.; formatting adjustments noted.

2023-03-15annual_review

Annual review — updated definitions and D.I./D.II.A. to include corrected gestational age.

Policy Summary

PayerCareSource Georgia

PolicyInhaled Nitric Oxide (iNO) coverage criteria

Policy CodePolicy Inhaled Nitric Oxide-MP-MM-1321

Change TypeNo material change

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionDocument that conventional therapies have failed or are expected to fail and provide objective evidence of PPHN when requesting initiation of iNO for near‑term/term infants.

SourceLink

On This Page

Clinical actionConsider discontinuation if lack of positive response or inability to wean O2 and/or iNO

Conventional therapies must have failed or be expected to fail before initiating iNO; these include mechanical ventilation, high FiO2 (80–100%), high‑frequency oscillatory ventilation (HFOV), induction of respiratory alkalosis, neuromuscular blockade, and sedation.

Mechanical ventilation
High FiO2 (80–100%)
High‑frequency oscillatory ventilation (HFOV)
Induction of respiratory alkalosis
Neuromuscular blockade
Sedation

Note

No step therapy specified in these sections

No step therapy requirements are described in the provided sections of the document.

Documentation Required

Documentation required for continuation beyond 3 days

Medical record documentation must support continued use of iNO beyond 3 days, demonstrating a positive clinical response and ability to wean oxygen and/or iNO.

Evidence of positive response to iNO
Documentation of attempts/ability to wean oxygen and/or iNO

Note

References/revision history provided; no submission requirements listed here

References and revision history are included in the policy, and the provided sections do not list specific submission requirements for prior authorization.

Denial Risk

Denial risk for not‑medically‑necessary indications

Use of iNO for indications identified as not medically necessary (including congenital diaphragmatic hernia; acute bronchiolitis; bronchopulmonary dysplasia; acute pulmonary embolism; acute respiratory distress syndrome; acute lung injury; lung or liver transplantation; pulmonary fibrosis; hemorrhagic shock; pneumonectomy post trauma; cystic fibrosis; malaria) may be denied.

Congenital diaphragmatic hernia
Acute bronchiolitis
Bronchopulmonary dysplasia (BPD)
Acute pulmonary embolism
Acute respiratory distress syndrome (ARDS)
Acute lung injury
Lung transplantation
Liver transplantation
Pulmonary fibrosis
Hemorrhagic shock
Pneumonectomy post trauma
Cystic fibrosis
Malaria

Note

No denial triggers or explicit authorization requirements in these sections

No denial triggers or explicit authorization requirements are present in these provided document sections.

Calculation example24 weeks gestational age at birth + 10 weeks old = 34 weeks corrected gestational age

Extracorporeal Membrane Oxygenation (ECMO)

DefinitionTemporary support of heart and lung function by partial cardiopulmonary bypass (up to 75% of cardiac output) for reversible cardiopulmonary failure.

Clinical roleUsed for patients with reversible cardiopulmonary failure from pulmonary, cardiac, or other disease

Relation to iNOECMO is referenced as a separate advanced support modality in definitions supporting respiratory failure management

Oxygen Index (OI)

FormulaOI = Mean Airway Pressure x FiO2 x 100 / PaO2

PurposeUsed to assess severity of hypoxic respiratory failure and persistent pulmonary hypertension of the newborn (PPHN)

Policy useAbnormal OI/arterial blood gases are acceptable objective evidence of PPHN for iNO initiation criteria

Persistent Pulmonary Hypertension of the Newborn (PPHN)

DefinitionFailure of the pulmonary vasculature to relax at birth resulting in increased pulmonary arterial pressure and resistance leading to shunting of deoxygenated blood into the systemic circulation.

Clinical consequencesResults in hypoxic respiratory failure and may be demonstrated by echocardiography, right heart catheterization, or abnormal OI/ABGs

Policy relevanceEvidence of PPHN is required (echo, right heart cath, or abnormal OI/ABGs not due to another condition) for iNO initiation in nearterm/term infants

2024-01-31annual_review

Annual review — updated D. IV. formatting and references; approved at Committee.

2025-01-15annual_review

Annual review with updates to background, definitions, D.II.D., III and references; approved at Committee.

2025-11-05revision

Updated references; approved at Committee (annual review).

2026-02-01effective_dateLatest

Policy effective date set to 2026-02-01 following prior updates and committee approval.