Therapeutic Utilization of Inhaled Nitric Oxide
Customize your policy alerts
Sign up for Ambetter Nevada Policy CP.MP.87 alerts
Get alerted when Policy CP.MP.87 changes without checking for updates manually.
Monitor payer policy activity
Governs medical necessity criteria and continuation for inhaled nitric oxide therapy for neonates, infants, children, and select adult indications (including COVID-19/ARDS rescue therapy) for members of Ambetter Nevada (Centene-affiliated health plans).
Updated oxygen index (OI) threshold in criteria I.A.6. from >20 to 25.
Moved a criterion (I.A.7.) into continuation criteria (III.A.1.) and removed criteria under III.A.1.
Added iNO as medically necessary for COVID-19 severe ARDS with hypoxemia despite optimized ventilation and other rescue strategies.
Continuation criteria clarified to require prior meeting of initial approval criteria and define response parameters (PaO2 increase ≥20 mm Hg or 20% decrease in OI).
Background updated; condensed criteria statement II regarding use in premature infants <34 weeks gestational age to allow case-by-case review using criteria for ≥34 weeks.
Added indication I.B.1.a.3) right ventricular failure.
Coverage and Medical Necessity Criteria
Initial Therapy Criteria
Covered when ANY one of the following indication groups are met and other listed conditions apply:
OI = (mean airway pressure × FiO2 × 100) / PaO2; see Definitions for calculation.
See continuation criteria for expectations about weaning/transition to other vasodilators.
NIH and guideline context: rescue use only; not routine therapy.
Continuation Therapy
Covered continuation when ALL of the following apply:
Extended administration beyond 72 hours requires secondary medical director review; weaning protocol details in policy (decrease by 50% every 4–6 hours while OI ≤10, stepwise reductions to discontinuation).
Not Medically Necessary
Safety and effectiveness have not been established for these indications; requests for these indications will be denied.
Key referenced criteria elements
Coverage and medical necessity criteria reference neonatal gestational age, oxygen index thresholds, and specific indications like pulmonary hypertension and right ventricular failure.
Case-by-case review permitted for <34 weeks per policy.
OI is calculated as (mean airway pressure × FiO2 × 100) / PaO2.
Added in revision history as an explicit indication.
See revision history for terminology change.
Use of inhaled nitric oxide (iNO) for indications listed in the policy’s Not Medically Necessary section is not covered. Examples include, but are not limited to, acute bronchiolitis, bronchopulmonary dysplasia (BPD), congenital diaphragmatic hernia (CDH) except as a bridge to repair, acute respiratory distress syndrome (except where specifically allowed in the policy), acute lung injury, treatment in adults with positive vaso-reactivity testing, post-operative cardiac surgery in adults, and vaso-occlusive crises in sickle cell disease. These indications are considered not medically necessary because safety and effectiveness have not been established.
This policy no longer includes ICD-10 diagnosis code lists; explicit ICD-10 exclusions were removed during recent revisions. Requests should therefore be evaluated against the written clinical criteria in the policy (gestational-age requirements, oxygenation thresholds, documented response to iNO, and other specified conditions) rather than relying on a removed code list.
The policy identifies specific uses that are considered not medically necessary. Representative examples called out in the policy include acute bronchiolitis, bronchopulmonary dysplasia (BPD), and congenital diaphragmatic hernia (CDH) except when used as a bridge to repair. Other NMN examples enumerated are acute respiratory distress syndrome (when not meeting the policy’s ARDS rescue criteria), acute lung injury, treatment in adults for positive vaso-reactivity testing, post‑operative adult cardiac surgery, and vaso‑occlusive crises in sickle cell disease.
Clinical evidence and the policy state that routine use of iNO is not supported in premature infants born at <34 weeks gestational age. However, the policy allows that requests to initiate iNO in these premature infants may be reviewed on a case‑by‑case basis, applying the same clinical criteria used for premature newborns ≥34 weeks gestational age (see section I). When considered, documentation should address gestational age, prior conventional therapy attempts, oxygenation metrics, and rationale for deviating from routine practice.
Billing and Coding
| 94799 | Unlisted pulmonary service or procedure |
| J80 | Included in ICD-10 codes added (document note) |
| J96.01 | Included in ICD-10 codes added (document note) |
| U07.1 | Included in ICD-10 codes added (document note) |
| U07.2 | Included in ICD-10 codes added (document note) |
| No codes listed |
Prior Authorization, Documentation, and Provider Responsibilities
Prior authorization required; extended use needs review
Prior authorization is required for initiation of inhaled nitric oxide (iNO) for covered indications per the policy's medical necessity criteria; continuation beyond initial approval that extends iNO administration beyond 72 hours requires secondary review by a medical director.
- CPT note: unlisted pulmonary service/procedure referenced (94799) for billing guidance.
Premature infants (<34 wks) — case-by-case PA review
Prior authorization requests must follow Health Plan procedures; initiation of iNO in premature infants <34 weeks gestational age may be reviewed on a case-by-case basis using the criteria for infants ≥34 weeks.
- Policy states that literature does not support routine use in <34 weeks and allows case-by-case review.
Adjunct vasodilator initiation expected during iNO
For perioperative management in infants/children, initiation of alternative systemic or enteral pulmonary vasodilator therapy (e.g., sildenafil) is expected during iNO administration with intent to wean or discontinue iNO per the continuation criteria.
- This expectation applies to perioperative indications such as post-cardiac bypass PAH, perioperative stabilization of hypoxia, or right ventricular failure.
No specified step therapy requirements
No formal step therapy protocol is specified in the policy; the document does not impose a prior trial-of-therapy sequence before iNO for the covered indications described.
- Policy content notes expectations for adjunct vasodilator initiation but does not define mandatory step therapy requirements.
Required clinical oxygenation and PH documentation
Provide documented oxygenation metrics and clinical data to support medical necessity: PaO2, FiO2, mean airway pressure (to calculate Oxygen Index), and evidence of pulmonary hypertension (clinical exam or echocardiogram); if a trial is performed, document response (PaO2 increase ≥20 mm Hg or 20% decrease in OI after up to 40 ppm trial).
- Include the OI calculation: (mean airway pressure × FiO2 × 100) / PaO2.
- If trialed, record dose, duration (up to 40 ppm), and objective response measures.
Document indication, criteria application, and standards alignment
Document the specific clinical indication, how the member meets the policy criteria (including gestational age and OI thresholds), prior use and failure of conventional therapies, and that the care decision aligns with generally accepted standards of medical practice and applicable coverage documents.
- For neonatal hypoxic respiratory failure, document failure of conventional therapies (high FiO2 80–100%, mechanical ventilation, HFV, alkalosis induction, neuromuscular blockade/sedation).
- For continuation requests, document prior meeting of initial criteria and evidence of response or initiation of a weaning protocol.
Denial risk for not medically necessary indications
Requests for iNO for indications listed as not medically necessary will be denied; examples include acute bronchiolitis, bronchopulmonary dysplasia (BPD), congenital diaphragmatic hernia except as a bridge to repair, and acute respiratory distress syndrome except where explicitly allowed.
- Also includes acute lung injury, treatment in adults with positive vaso-reactivity testing, post-op cardiac surgery in adults, and vaso-occlusive crises in sickle cell disease.
Denial risk for requests not meeting numeric/gestational criteria
Requests that do not meet explicit policy criteria — for example, failure to meet gestational-age rules or the oxygen index thresholds (OI > 25 for initiation, continuation response definitions) — may be denied; the policy also removed ICD-10 code mappings and notes that nonconforming requests will be evaluated against the written criteria.
- Ensure submitted OI calculations and PaO2/FiO2 data support the stated OI and thresholds.
- If member is <34 weeks gestational age, indicate whether a case-by-case rationale per policy II is provided.
Clinical Background and Scope
Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator used to improve oxygenation in appropriate clinical settings. The policy recognizes iNO’s role as a rescue or adjunctive therapy in term/near‑term neonates with hypoxic respiratory failure and pulmonary hypertension and permits use in select perioperative pediatric indications and as a rescue therapy for severe acute respiratory distress (including ARDS related to COVID‑19) when conventional measures have failed. The document emphasizes that iNO administration should be titrated and tapered if no rapid improvement is observed, that continuation criteria require demonstration of response (for example, PaO2 increase ≥20 mm Hg or 20% decrease in oxygen index after an up to 40 ppm trial), and that extended administration beyond 72 hours requires secondary medical director review.
Definitions and Response Metrics
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.