Inhaled Nitric Oxide (iNO) in Preterm/Neonatal Infants — Medical Coverage Policy
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Clinical coverage policy governing use of inhaled nitric oxide for newborns and infants (including perioperative pediatric use) under Baylor Scott & White Health Plan; applies across lines of business and informs medical necessity determinations and retrospective review processes.
Updated Medical Necessity Requirements and updated exclusions; updated Background Section; Updated References.
Added CPT Code 94799 and reformatted existing criteria.
Coverage Criteria for Inhaled Nitric Oxide (iNO)
Covered Indications and Continuation Criteria
Covered when ALL of the following are met for hypoxic respiratory failure in newborns:
Providers should attempt conventional therapies prior to iNO initiation
Therapy greater than 4 days requires medical necessity review
All indications for inhaled nitric oxide (iNO) that are not specifically listed as covered in this policy are considered unproven or investigational. Examples of these non-covered indications include, but are not limited to, use in preterm infants <34 weeks gestation with pulmonary disease and management of pulmonary hypertension in congenital diaphragmatic hernia.
Use of inhaled nitric oxide in preterm infants <34 weeks gestation is considered unproven/investigational under this policy and is therefore not medically necessary.
Coding — CPT and ICD-10 Guidance
| 94799 | Pulmonary Diagnostic Testing and Therapies (CPT listed in policy) |
| I27.0 | Primary pulmonary hypertension |
| I27.2 | Secondary pulmonary hypertension |
| P07.37 | Preterm newborn 34 weeks |
| P07.38 | Preterm newborn 35 weeks |
| P07.39 | Preterm newborn 36 complete weeks |
| P28.5 | Respiratory failure of newborn |
| P29.30 | Pulmonary hypertension of newborn |
| P29.38 | Other persistent fetal circulation |
| P27.x | Chronic respiratory disease originating in the perinatal period (listed as not covered) |
Provider Actions, Documentation, and Denial Risks
Prior authorization not required; retrospective review applies
Prior authorization is not required for inhaled nitric oxide (iNO); the service is subject to retrospective review. CPT code 94799 is listed in the policy but prior authorization is not required prior to service.
- Prior authorization: Not required.
- Service subject to retrospective review.
Attempt conventional therapies before initiating iNO
Providers must document that conventional treatments were attempted and failed before initiating iNO, including mechanical ventilation, high concentrations of oxygen (80–100%), and neuromuscular blockade and/or sedation.
- Mechanical ventilation attempted
- High FiO2 (80–100%) trialed
- Neuromuscular blockade and/or sedation used when indicated
Required clinical documentation for medical necessity review
Clinical documentation must include gestational age at birth (≥34 weeks), clinical or echocardiographic evidence of pulmonary arterial hypertension, oxygen index (OI) calculation, oxygen requirement, prior conventional treatment attempts, and evidence of a weaning protocol when applicable.
- Gestational age at birth (document ≥34 weeks for covered indication)
- Clinical or echocardiographic evidence of pulmonary arterial hypertension (PAH)
- Oxygen Index (OI) calculation (MAP / PaO2 x 100) and OI value
- Documentation of prior conventional treatments (mechanical ventilation, FiO2 80–100%, neuromuscular blockade/sedation)
- Oxygen requirement (e.g., continued 80–100% O2) or evidence a weaning protocol has been initiated
Denial risk for unproven or investigational indications
Use of iNO for indications not listed in the policy may be denied; specifically, use in preterm infants <34 weeks gestation and for management of pulmonary hypertension in diaphragmatic hernia is considered unproven/investigational and may be denied.
- Preterm infants (<34 weeks gestation) — use considered unproven/investigational
- Management of pulmonary hypertension in diaphragmatic hernia — use considered unproven/investigational
Risk of denial for extended iNO therapy (>4 days) without documented criteria
Continuation of iNO therapy beyond 4 days is subject to medical necessity review and may be denied if continuation criteria are not met (member must have met initial criteria and show ongoing need or a weaning protocol).
- Continuation criteria: member previously met initial approval criteria AND (continued O2 requirement of 80–100% OR a weaning protocol initiated)
- Note: iNO use >4 days requires medical necessity review and may be denied if criteria are not met
Background
Inhaled nitric oxide (iNO) acts as a selective pulmonary vasodilator to decrease pulmonary vascular resistance, improve ventilation–perfusion matching, and reduce right‑to‑left shunting, with the clinical aim of improving arterial oxygenation. It is used in newborns and infants to treat hypoxic respiratory failure associated with pulmonary hypertension and to reduce the need for extracorporeal membrane oxygenation in appropriate term or near‑term patients.
Definitions and Key Parameters
Revision History and Policy Changes
Updated medical necessity requirements and exclusions; updated background section and references.
Removed statement regarding use of Medicare NCD or LCD specific InterQual criteria when available.
Updated Background section.
Added CPT code 94799 and reformatted existing criteria; other formatting and hyperlink updates to align with CMS and business entity requirements.
Policy created (new policy).
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