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    v1.0.28
    OpenPayerPolicy UpdatesPulmonologySelect Health inhaled nitric oxide Coverage Update…
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    Currentselect_healthPolicy CCP.1086

    Inhaled Nitric Oxide

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    This policy governs medical necessity and coverage for inhaled nitric oxide therapy, primarily for newborns with pulmonary hypertension and hypoxemic respiratory failure, and outlines investigational or noncovered uses. It applies to Select Health of South Carolina plan determinations.

    Policy Summary
    Payerselect_health
    PolicyInhaled Nitric Oxide
    Policy CodePolicy CCP.1086
    Change TypeRoutine review — no material changes
    Effective DateJun 1, 2024
    Last ReviewMay 1, 2026
    Next Review DateSep 1, 2027
    Key ActionObtain prior authorization and document gestational age ≥35 weeks, absence of congenital diaphragmatic hernia, evidence of pulmonary hypertension, and treatment in a Level 3/4 NICU with ECMO referral access.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥35gestational age threshold
    >25oxygenation index threshold
    20 ppminitial concentration
    Not coveredpreterm use (<35w)

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Investigational
    other uses

    Coverage Criteria: Medical Necessity

    inv-01: Neonatal persistent pulmonary hypertension / hypoxemic respiratory failure — Covered when ALL of the following are met

    Covered when ALL of the following are met

    Neonatal persistent pulmonary hypertension / hypoxemic respiratory failure: Inhaled nitric oxide is a component treatment of respiratory failure associated with pulmonary hypertension; infants are ≥ 35 weeks gestation; no congenital diaphragmatic hernia; therapy performed in centers with Level 3 or Level 4 neonatal intensive care units and referral access to extracorporeal membrane oxygenation.gestational age ≥ 35 weeks; oxygenation index > 25 is a cited evidence threshold; initial concentration 20 ppm noted in evidence

    Guidelines (AHA/ATS) support use to reduce need for ECMO in term/near‑term infants with oxygenation index >25; evidence shows benefit at initial 20 ppm in term/near‑term mechanically ventilated newborns without diaphragmatic hernia.

    Inhaled nitric oxide is considered investigational/not medically necessary for uses outside the covered neonatal indication. Specifically, all other uses of inhaled nitric oxide are not medically necessary, and its use in infants less than 35 weeks gestation is investigational and not medically necessary.

    The policy’s covered indication is limited to newborns with respiratory failure associated with pulmonary hypertension who meet all stated criteria (including gestational age ≥ 35 weeks, absence of congenital diaphragmatic hernia, and treatment in a Level 3 or 4 NICU with ECMO referral access). Uses that do not meet those criteria are subject to denial as not medically necessary.

    Contraindications to inhaled nitric oxide include severe left ventricular dysfunction, congenital heart disease with a right-to-left shunt, and cyanotic heart disease. These conditions increase the risk of harm and are explicitly listed as contraindications in the policy.

    The policy also warns that abrupt discontinuation can worsen oxygenation, increase pulmonary artery pressure, and precipitate rebound pulmonary hypertension syndrome, which is important to consider when managing therapy in patients with underlying cardiac dysfunction.

    Inhaled nitric oxide is not recommended for routine prevention of bronchopulmonary dysplasia (BPD). Guideline and evidence summaries do not support routine prophylactic use for BPD prevention.

    The policy notes uncertain benefit in preterm infants (particularly those ≤ 34–35 weeks gestation) and states that more studies are needed to define the role of inhaled nitric oxide in premature neonates. Use in these populations is considered investigational and generally not medically necessary except in carefully selected circumstances supported by evidence.

    Coding and Clinical Thresholds

    Related codes (commonly submitted)mixed
    J3490Unclassified drugs
    94799Unlisted pulmonary service or procedures
    3E0F7SDPCS Procedure Code
    Related diagnosis/procedure codes (documented)ICD-10
    ICD-10-Introduction of Nitric Oxide Gas into Respiratory Tract, Via Natural or Artificial Opening
    inv-07: Oxygenation index — threshold cited (exceeds 25)
    Oxygenation index thresholdCovered when oxygenation index exceeds 25 (OI > 25)
    Clinical relevanceOI >25 identifies severe hypoxemic respiratory failure in term/near‑term infants and is the guideline threshold supporting iNO to reduce ECMO use
    Alternative measure notedPartial pressure of arterial oxygen <100 mmHg on 100% oxygen is an alternative criterion in some studies
    inv-08: Initial concentration — initial dosing (20 ppm)
    Initial inhaled nitric oxide concentrationInitial concentration shown effective: 20 parts per million (20 ppm)
    Population for initial dose

    Provider Actions: Authorization, Documentation, Denials

    Prior Authorization

    Prior authorization: newborns ≥35 weeks — show indication and facility level

    Inhaled nitric oxide may be medically necessary for newborns when all policy criteria are met: it must be used as part of treatment for respiratory failure associated with pulmonary hypertension in infants who are ≥ 35 weeks gestation, without congenital diaphragmatic hernia, and administered in a center with a Level 3 or Level 4 NICU with ECMO referral access. Prior authorization may be required by the plan and billing commonly uses unclassified drug and procedure codes; include indication and facility level in the authorization request.

    • Ensure gestational age documented as ≥ 35 weeks.
    • Document absence of congenital diaphragmatic hernia.
    • Specify NICU level (Level 3 or Level 4) and ECMO referral access in the request.
    • Include relevant billing codes (e.g., J3490, 94799, PCS 3E0F7SD) when submitting authorization/billing.
    Step Therapy

    Alternatives / step therapy: document standard medical care tried or considered

    Background and Rationale

    Persistent pulmonary hypertension of the newborn (PPHN) represents failure of the normal postnatal decrease in pulmonary vascular resistance and transition to low pulmonary vascular tone. It is an important cause of severe hypoxemic respiratory failure in neonates and is associated with notable mortality.

    Inhaled nitric oxide is a selective pulmonary vasodilator approved to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term neonates with hypoxic respiratory failure due to pulmonary hypertension. Clinical guidelines identify inhaled nitric oxide as the preferred pulmonary vasodilator for severe hypoxemia from PPHN and report that it lowers the need for ECMO in term and late preterm infants without serious long-term adverse effects.

    Adverse risks relevant to clinical management include the potential for methemoglobinemia, rebound pulmonary hypertension if therapy is stopped abruptly, and the chance of worsening left heart failure in patients with significant left ventricular dysfunction; these considerations inform the policy’s gestational age, contraindication, and facility-level requirements.

    Definitions

    inv-15: Inhaled nitric oxide — definition and mechanism
    DefinitionInhaled nitric oxide (iNO) is a selective pulmonary vasodilator gas administered by inhalation to improve oxygenation and reduce need for extracorporeal membrane oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension.
    Mechanism of actionNO increases intracellular cyclic GMP via nitric oxide synthase pathways, causing pulmonary vasodilation and relaxation of airway smooth muscle; it is delivered by inhalation to selectively dilate the pulmonary vasculature.
    Adverse effects to monitorPotential adverse effects include methemoglobinemia, rebound pulmonary hypertension on abrupt discontinuation, nitrogen dioxide toxicity, and possible worsening of left heart failure—monitor accordingly.
    inv-16: Oxygenation index — definition and clinical use
    DefinitionOxygenation index (OI) is a clinical parameter used to assess severity of hypoxemic respiratory failure and to guide therapy decisions such as iNO or ECMO referral.
    Policy Summary
    Payerselect_health
    PolicyInhaled Nitric Oxide
    Policy CodePolicy CCP.1086
    Change TypeRoutine review — no material changes
    Effective DateJun 1, 2024
    Last ReviewMay 1, 2026
    Next Review DateSep 1, 2027
    Key ActionObtain prior authorization and document gestational age ≥35 weeks, absence of congenital diaphragmatic hernia, evidence of pulmonary hypertension, and treatment in a Level 3/4 NICU with ECMO referral access.
    SourceLink
    On This Page
    Coverage Criteria: Medical NecessityCoding and Clinical ThresholdsProvider Actions: Authorization, Documentation, DenialsBackground and RationaleDefinitions
    Term or near‑term mechanically ventilated newborns with hypoxemic respiratory failure (no diaphragmatic hernia)
    Primary outcome at this dose20 ppm reduced need for extracorporeal membrane oxygenation in randomized trials and meta‑analyses
    inv-09: Gestational age threshold — covered use gestational age (≥ 35 weeks)
    Gestational age threshold for covered useInfants must be ≥ 35 weeks gestation to meet coverage criteria
    RationalePolicy and evidence focus on term/near‑term infants; benefit in infants ≤34 weeks is uncertain or not medically necessary
    Regulatory contextFDA approval and guideline evidence pertain to term and near‑term neonates (>34 weeks) with hypoxic respiratory failure

    Before initiating inhaled nitric oxide, provide or document that standard, guideline-directed medical care alternatives were tried or considered; the policy lists standard medical care from peer-reviewed literature as alternative covered services for respiratory and pulmonary disease in infants.

    • Standard medical care per peer-reviewed journals for asthma, respiratory distress, chronic lung disease, and pulmonary disease in infants is the alternative.
    • Document rationale if bypassing stepwise use of standard therapies and why inhaled nitric oxide is indicated.
    Documentation Required

    Required documentation to support coverage

    Document clinical details that support medical necessity: gestational age, absence of congenital diaphragmatic hernia, evidence of pulmonary hypertension/respiratory failure, and the treating facility's NICU level and ECMO referral access. Providers must also consult coding manuals and bill appropriately using the commonly submitted codes.

    • Gestational age (record showing ≥ 35 weeks).
    • Clinical evidence of pulmonary hypertension and hypoxemic respiratory failure.
    • Negative documentation for congenital diaphragmatic hernia.
    • Facility level (Level 3 or Level 4 NICU) and statement of ECMO referral access.
    • Include applicable billing codes or explanation for use of unlisted codes per coding manuals.
    Denial Risk

    Denial triggers: infants <35 weeks and non‑indicated uses

    The following uses will be denied: any use of inhaled nitric oxide outside the stated neonatal pulmonary hypertension indication, and use in infants less than 35 weeks gestation is investigational and not medically necessary.

    • Use in infants < 35 weeks gestation — investigational / not medically necessary.
    • All other uses of inhaled nitric oxide not described in the covered criteria — not medically necessary.
    Guideline thresholdAHA/ATS guidelines support use of inhaled nitric oxide when OI exceeds 25 (Class I; Level of Evidence A)
    Clinical useAn OI >25 identifies infants at higher risk who may benefit from iNO to reduce need for ECMO; used alongside other clinical data to determine treatment.