Currentmclaren health planPolicy 15-02

Inhaled Nitric Oxide (iNO)

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This policy governs medical necessity criteria, approved indications, and investigational exclusions for inhaled nitric oxide (iNO) for neonates, children, and adults under McLaren Health Plan.

Policy Summary

Payermclaren health plan

PolicyInhaled Nitric Oxide (iNO)

Policy CodePolicy 15-02

Change TypeNo material changes

Effective DateMay 21, 2024

Next Review Date

Key ActionObtain initial approval for up to 72 hours when neonatal criteria are met and document gestational age, absence of unrepaired congenital diaphragmatic hernia, and failure or anticipated failure of conventional therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

72hinitial approval duration

>34wgestational age threshold

6investigational uses listed

Coverage Criteria for Inhaled Nitric Oxide (iNO)

Initial Treatment (initial approval for 72 hours)

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Currentmclaren health planPolicy 15-02

Inhaled Nitric Oxide (iNO)

Customize your policy alerts

Sign up for mclaren health plan Policy 15-02 alerts

Get alerted when Policy 15-02 changes without checking for updates manually.

Monitor payer policy activity

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This policy governs medical necessity criteria, approved indications, and investigational exclusions for inhaled nitric oxide (iNO) for neonates, children, and adults under McLaren Health Plan.

Policy Summary

Payermclaren health plan

PolicyInhaled Nitric Oxide (iNO)

Policy CodePolicy 15-02

Change TypeNo material changes

Effective DateMay 21, 2024

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

72hinitial approval duration

>34wgestational age threshold

6investigational uses listed

Coverage Criteria for Inhaled Nitric Oxide (iNO)

Initial Treatment (initial approval for 72 hours)

Neonatal hypoxic respiratory failure criteria: Neonate > 34 weeks gestation AND (a) does NOT have an unrepaired congenital diaphragmatic hernia AND (b) conventional therapies have all failed or are anticipated to fail (including high concentrations of oxygen, hyperventilation, high frequency ventilation, induction of alkalosis, neuromuscular blockade, and sedation)Initial approval 72 hours

See documentation requirements and prior authorization conditions.

Additional Covered Indications

Covered when the documented clinical indication matches:

Postoperative pediatric pulmonary hypertension: Management of postoperative pulmonary hypertension in infants or children following heart or lung surgery

Assessment of pulmonary vasoreactivity: Use as a method of assessing pulmonary vasoreactivity in children and adults with pulmonary hypertension

Experimental or Investigational (Not covered)

iNO is considered experimental or investigational for ALL other indications, including but not limited to:

Investigational indications list: 1) Premature neonates ≤ 34 weeks gestation with hypoxic respiratory failure; 2) Adults and children not meeting the medical necessity criteria for acute hypoxemic respiratory failure; 3) Acute respiratory distress syndrome (ARDS) or acute lung injury; 4) Acute treatment of sickle cell vaso-occlusive crisis; 5) Postoperative use in adults with congenital heart disease; 6) In lung transplantation during and/or after graft reperfusion.

The policy explicitly excludes or considers investigational several specific uses of inhaled nitric oxide (iNO). These include use in premature neonates ≤ 34 weeks gestation with hypoxic respiratory failure; treatment of acute respiratory distress syndrome (ARDS) or acute lung injury; postoperative use in adults with congenital heart disease; administration during and/or after graft reperfusion in lung transplantation; and acute treatment of sickle cell vaso-occlusive crisis. Use outside the covered neonatal and pediatric indications listed in this policy falls into the investigational category and is subject to denial.

All indications not explicitly meeting the medical necessity criteria above are considered not medically necessary or investigational under this policy. Treatments listed among the investigational examples (such as preterm neonates ≤ 34 weeks, ARDS, adult postoperative congenital heart disease, sickle cell vaso-occlusive crisis, and peri-reperfusion use for lung transplantation) should be regarded as non-covered unless specific medical necessity criteria are met and documented.

Coding and Related Criteria

Referenced product inserts (no billing codes listed)mixed

GENOSYL	GENOSYL (nitric oxide for inhalation) package insert referenced
INOmax	INOmax (nitric oxide for inhalation) package insert referenced
Noxivent	Noxivent (nitric oxide for inhalation) package insert referenced

Gestational age

Gestational age threshold> 34 weeks gestation

ApplicabilityNeonates meeting hypoxic respiratory failure criteria (see definitions)

Exclusion for prematurityPremature neonates ≤ 34 weeks are considered investigational and not covered

Documentation requiredClinical record must support gestational age > 34 weeks for neonatal iNO use

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Initial approval conditions

Initial approval is granted for up to 72 hours when the following initial criteria for treatment are met.

Initial approval duration: 72 hours
Applies to neonates > 34 weeks gestation when both (a) and (b) are met: (a) no unrepaired congenital diaphragmatic hernia; (b) conventional therapies have failed or are anticipated to fail

Documentation Required

Required clinical documentation for neonatal use

For neonatal use, document the following in the medical record and prior authorization request: gestational age, absence of unrepaired congenital diaphragmatic hernia, and evidence that conventional therapies have failed or are anticipated to fail. Conventional therapies include administration of high concentrations of oxygen, hyperventilation, high frequency ventilation, induction of alkalosis, neuromuscular blockade, and sedation.

Document gestational age (> 34 weeks for covered neonatal use)
Document absence of unrepaired congenital diaphragmatic hernia
Document failure of or anticipated failure of conventional therapies (list above)

Background

Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator used to improve oxygenation by reducing pulmonary vascular resistance. The FDA-approved neonatal indication is for term and near-term infants with hypoxic respiratory failure to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO). This policy limits routine covered neonatal use to neonates > 34 weeks gestation who meet the specific medical necessity requirements described elsewhere in the document.

Definitions

Hypoxic respiratory failure (neonates)

DefinitionNeonatal respiratory failure with hypoxemia associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Context of useIndication for FDA‑approved iNO therapy in term and near‑term neonates (> 34 weeks gestation).

Therapies to accompany assessmentUsed in conjunction with ventilatory support and other appropriate agents per clinical judgment.

Exclusion noteNot applicable to premature neonates (≤ 34 weeks) where iNO is considered investigational.

Policy Summary

Payermclaren health plan

PolicyInhaled Nitric Oxide (iNO)

Policy CodePolicy 15-02

Change TypeNo material changes

Effective DateMay 21, 2024

Next Review Date

SourceLink

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