Therapeutic Utilization of Inhaled Nitric Oxide
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Defines medical necessity, initiation, and continuation criteria for inhaled nitric oxide therapy for neonates, infants, children, and selected adults (including COVID-19 severe ARDS) for Arizona Complete Health members.
Updated oxygen index threshold in criteria I.A.6 from >20 to >25 and moved/removed related criteria per revision log.
Added iNO as medically necessary for COVID-19 with severe ARDS and hypoxemia despite optimized ventilation and other rescue strategies.
Clarified continuation criteria and noted extended administration beyond 72 hours requires secondary medical director review.
Background updated with no impact on criteria; oxygen index in criteria I.A.6. changed multiple times and was ultimately set to 25 in a later revision.
Condensed criteria statement II: while literature predominantly does not support iNO in premature infants <34 weeks gestational age, requests may be reviewed case-by-case using criteria for premature newborns ≥34 weeks in section I.
Additional indication added under I.B.1.a.3) for right ventricular failure.
Criteria IV. updated from 'adult respiratory distress' to 'acute respiratory distress'.
Medical Necessity and Coverage Criteria
Initial Therapy — Neonates with hypoxic respiratory failure (≥34 weeks GA)
Covered when ALL of the following are met
Initial Therapy — Perioperative management in infants and children (≥34 weeks GA)
Covered when BOTH of the following are met
Initial Therapy — COVID-19 with severe ARDS
Covered when BOTH of the following are met
Continuation Therapy
Covered when ALL of the following are met (member previously met initial approval criteria AND one of the response conditions)
Summary of documented criteria elements and revisions
Policy contains multiple sections (I, II, III, IV) with neonatal, pediatric and adult criteria; partial content in this window documents revisions and handling of premature infants.
Case-by-case review required; use section I criteria as reference
Used as a quantitative trigger in criteria I.A.6
New indication added to policy
Inhaled nitric oxide (iNO) is considered not medically necessary for indications other than those specifically listed as medically necessary in this policy. Examples of excluded indications include, but are not limited to: acute bronchiolitis; bronchopulmonary dysplasia (BPD); congenital diaphragmatic hernia (except when used as a bridge to surgical repair as noted in the policy); acute respiratory distress syndrome (except the limited, specified indications in this policy); acute lung injury; treatment in adults based solely on positive vaso-reactivity testing; routine post‑operative cardiac surgery use in adults; and vaso‑occlusive crises in individuals with sickle cell disease. These exclusions reflect that safety and effectiveness for these uses have not been established.
The policy notes that the medical literature predominantly does not support routine use of iNO in premature infants born at 34 weeks gestational agecase‑by‑case basis; reviewers should apply the criteria for premature newborns ≥34 weeks GA in section I when evaluating such requests and ensure supporting documentation justifies deviation from the general exclusion.
For adults with acute respiratory distress syndrome (ARDS), including ARDS from COVID‑19, the evidence does not support routine use of iNO. Guideline panels recommend against the routine use of iNO in mechanically ventilated adults with ARDS; randomized and systematic review data show only transient improvements in oxygenation without reductions in mortality or other important clinical outcomes and potential for harm (for example, increased renal impairment).
Routine initiation of iNO in premature infants born at 34 weeks gestational agenot medically necessary absent case‑by‑case justification. When a provider requests initiation for a premature infant <34 weeks GA, the request should include clinical evidence and rationale; reviewers may deny requests that lack documentation demonstrating potential benefit or that do not meet the limited circumstances outlined for review.
Billing and Coding
| 94799 | Unlisted pulmonary service or procedure |
| No codes listed |
Provider Requirements, Authorization, and Documentation
Denial Triggers
Requests that do not meet the initial or continuation criteria in this policy (including indications listed in Section IV) may be denied. Denial is also possible when required documentation is incomplete or when criteria specific to gestational age and oxygenation are not satisfied.
- Denial triggers: Failure to meet initial or continuation criteria; indications listed in Section IV; insufficient documentation.
- Extended iNO administration beyond 72 hours without secondary medical director review may be subject to denial.
Premature Infant Initiation Risk
Initiation of iNO in premature infants <34 weeks gestational age at birth is generally not supported by the medical literature and may be denied unless a case-by-case review supports use. Requests for these infants may be considered only with special-case review and when documentation addresses how the criteria for infants ≥34 weeks are met or why deviation is clinically necessary.
- Premature infant initiation risk: iNO requests for infants <34 weeks GA may be denied unless criteria for ≥34 weeks are met or exceptional circumstances are documented and reviewed.
- Case-by-case review: Provider must justify initiation with clinical rationale and supporting data for special review.
Required Documentation
Providers must include key clinical information to support authorization requests and continuations. Complete documentation enables timely review and reduces denial risk.
- Required documentation: gestational age at birth, evidence of pulmonary hypertension (e.g., echocardiogram findings or clear clinical evidence despite maximal respiratory support), prior and concurrent conventional therapies (mechanical ventilation, high FiO2, HFV, alkalosis induction, neuromuscular blockade, sedation), oxygenation metrics (PaO2, FiO2, mean airway pressure, OI calculations), and response to iNO (PaO2 increase ≥20 mmHg or ≥20% decrease in OI).
- Documentation of prior authorization decisions and dates, dosing (trial up to 40 ppm, recommended 20 ppm), and any adjunct vasodilator therapy plans.
Documentation of Gestational Age and Oxygenation
Explicit recording of gestational age and objective oxygenation measures is required for initial and continuation determinations. Revision logs reflect changes to OI thresholds and criteria positioning; ensure submitted data match current policy thresholds.
- Documentation of gestational age and oxygenation: include exact gestational age at birth and serial oxygenation data (PaO2, FiO2, mean airway pressure, and calculated OI).
- Operational note: Be aware of policy updates to OI thresholds (e.g., changes between >20 and >25) — use the current policy value when justifying requests.
Perioperative Weaning Strategy
For perioperative use, initiate alternative systemic or enteral pulmonary vasodilator therapy with the explicit intent to wean or discontinue iNO. Document the weaning plan and timing relative to surgery and iNO administration.
- Perioperative weaning strategy: When iNO is used perioperatively (including for congenital heart defect repair, perioperative stabilization, right ventricular failure, or pulmonary hypertensive crisis), document initiation of alternative vasodilators (e.g., sildenafil) during iNO with a clear plan to wean/discontinue iNO.
- Include timeline for transition, monitoring parameters, and criteria for successful wean (e.g., stability of OI, FiO2 requirements).
No Explicit Step Therapy Sequence Specified
This policy section does not specify a formal step therapy sequence for iNO; the information below is informational only and does not impose a step-therapy requirement.
- No explicit step therapy specified: There is no mandated step sequence prior to iNO in this portion of the policy.
- Informational: Providers should still document failure of conventional therapies as required for initiation criteria.
Clinical Background and Rationale
Inhaled nitric oxide is a selective pulmonary vasodilator that reduces pulmonary vascular resistance and can improve ventilation‑perfusion matching. In term and near‑term neonates with hypoxic respiratory failure and pulmonary hypertension (such as persistent pulmonary hypertension of the newborn), iNO has been shown to rapidly improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in appropriately selected patients. The policy’s neonatal criteria reflect these benefits and require documentation of pulmonary hypertension, failure of conventional therapies, and oxygenation thresholds before initiation.
Key Definitions and Clinical Metrics
Policy Revision Log
Merged revision log entries from 11/24 and 07/24; finalized oxygen index (OI) threshold in I.A.6 as 25 and moved I.A.7 to III.A.1 with removal of the noted III.A.1 criteria.
Updated criteria language changing 'adult respiratory distress' to 'acute respiratory distress' and recorded approval of 11/24 revisions.
Corrected May 2024 revision log to note removal of administration route wording and updated OI in I.A.6 from ≥25 to >20; added additional indication I.B.1.a.3 for right ventricular failure.
Condensed criteria II to clarify case-by-case review for premature infants <34 weeks GA and corrected revision log entries regarding removed criteria and OI wording; references reviewed.
Minor rewording across multiple criteria, added recommended iNO doses in select criteria, removed 'within two hours' response requirement in II.B.1.e, and updated continuation notation from 48 to 72 hours; background updated with no impact on criteria.
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