ModifiedAmbetter GeorgiaPolicy CP.MP.87

Therapeutic Utilization of Inhaled Nitric Oxide

Customize your policy alerts

Sign up for Ambetter Georgia Policy CP.MP.87 alerts

Get alerted when Policy CP.MP.87 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines medical necessity, continuation, and non‑coverage criteria for initiation and ongoing use of inhaled nitric oxide therapy across neonatal, pediatric, and adult settings for members of Ambetter Georgia.

Policy Summary

PayerAmbetter Georgia

PolicyTherapeutic Utilization of Inhaled Nitric Oxide

Policy CodePolicy CP.MP.87

Change TypeMultiple material and editorial revisions (numeric threshold and indications added)

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation that clinical criteria are met (including gestational age, evidence of PAH, maximum conventional therapies trial, calculated OI, and response to up to 40 ppm trial).

SourceLink

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.

ModifiedAmbetter GeorgiaPolicy CP.MP.87

Therapeutic Utilization of Inhaled Nitric Oxide

Customize your policy alerts

Sign up for Ambetter Georgia Policy CP.MP.87 alerts

Get alerted when Policy CP.MP.87 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerAmbetter Georgia

PolicyTherapeutic Utilization of Inhaled Nitric Oxide

Policy CodePolicy CP.MP.87

Change TypeMultiple material and editorial revisions (numeric threshold and indications added)

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Added indications for case-by-case review of iNO initiation for preterm infants <34 weeks at birth to section II.

Updated oxygen index threshold in criteria I.A.6 from >20 to 25.

Added additional indication I.B.1.a.3) right ventricular failure.

Removed the requirement that iNO be administered via endotracheal tube or tracheostomy from criteria I.A.

Split continuation criteria into section III, and not medically necessary indications are now section IV.

Changed 'Review Date' in policy header to 'Date of Last Revision,' and 'Date' in the revision log table header to 'Revision Date.'

Updated criteria IV. wording from 'adult respiratory distress' to 'acute respiratory distress.'

OI > 25OI initiation threshold

≤ 10Weaning consideration

20 ppmRecommended start dose

40 ppmResponse trial upper dose

94799Referenced CPT

20→25OI updated

Coverage Criteria for Inhaled Nitric Oxide (iNO)

Initial therapy — Term/near‑term newborns (≥34 weeks GA)

Covered when ALL of the following are met

Term/near-term initiation: 1. Evidence of pulmonary arterial hypertension (PAH) by either: (a) well-documented clinical evidence of pulmonary hypertension despite maximal respiratory support; or (b) echocardiogram suggestive of PAH; 2. Absence of unrepaired congenital diaphragmatic hernia (CDH), except when used as a bridge to surgical repair; 3. Failure of conventional therapies such as mechanical ventilation, administration of high concentrations of oxygen (80–100%), high-frequency ventilation, induction of alkalosis, neuromuscular blockade, and/or sedation; 4. Oxygen index (OI) > 25.OI > 25

Applies to newborns ≥34 weeks gestational age.

Initial therapy — Perioperative management in children/infants ≥34 weeks GA

Covered when ALL of the following are met

Perioperative indications: 1. One of the following indications: (a) congenital heart defect with iNO used for vasodilation after cardiac bypass causing PAH, perioperative stabilization/management of hypoxia, or right ventricular heart failure; or (b) pulmonary hypertensive crisis associated with heart or lung surgery (including immediately pre- or post-operatively for congenital diaphragmatic hernia); 2. Initiation of alternative vasodilator therapy (e.g., sildenafil) during iNO administration with intent to wean or discontinue iNO.

Applies to children/infants ≥34 weeks gestational age.

Initial therapy — COVID-19 related ARDS (adults)

Covered when BOTH of the following are met

COVID-19 severe ARDS rescue: 1. Severe acute respiratory distress syndrome (ARDS) due to COVID-19; 2. Hypoxemia despite optimized ventilation and other rescue strategies. Note: If no rapid improvement in oxygenation is observed, treatment should be tapered off promptly.

Considered as rescue therapy; routine use is not recommended.

Continuation therapy

Covered when ALL of the following are met for members who previously met initial approval

Continuation response criteria: Either: (1) Response to an up to 40 ppm trial with recommended 20 ppm dose (response defined as PaO2 increase ≥20 mmHg or ≥20% decrease in oxygen index); OR (2) A weaning protocol initiated after a 4–6 hour period of stability indicated by FiO2 decreased/decreasing to 60–80% or oxygen index (OI) < 10.

Extended administration beyond 72 hours requires secondary medical director review.

Criteria changes and references to sections I–IV

Policy contains multiple criteria sections (I, II, III, IV) covering indications, case-by-case review for preterm infants <34 weeks, continuation criteria, and not medically necessary indications.

Premature infants <34 weeks: Requests for initiation of iNO therapy in premature infants <34 weeks gestational age at birth may be reviewed on a case-by-case basis with consideration of the criteria for premature newborns ≥34 weeks in section I.gestational age <34 weeks

Literature predominantly does not support routine iNO in this group.

Oxygen index threshold: The oxygen index threshold in section I.A.6 was revised to OI > 25.OI > 25

Numeric change recorded in the revision log.

Indications addition: Right ventricular failure was added to perioperative indications (I.B.1.a.3).clinical diagnosis: right ventricular failure

Requests for inhaled nitric oxide (iNO) for indications not listed in the policy's covered criteria are excluded. Examples of excluded indications include, but are not limited to: acute bronchiolitis, bronchopulmonary dysplasia (BPD), congenital diaphragmatic hernia (CDH) except when used as a bridge to surgical repair, acute respiratory distress syndrome (except as noted for specified COVID-19 rescue use), acute lung injury, post-operative cardiac surgery in adults, and vaso‑occlusive crises in sickle cell disease.

The policy language in section IV has been updated to replace the term 'adult respiratory distress' with 'acute respiratory distress' to clarify and standardize the excluded indication wording.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules before applying this policy.

Routine or other uses of iNO outside the specified covered indications are considered not medically necessary because safety and effectiveness have not been established. Guideline statements specifically recommend against routine use of iNO in mechanically ventilated adults with COVID‑19, and other off‑label or unsupported indications are excluded from coverage.

Section IV of the policy lists uses of iNO that are considered not medically necessary. The document notes that several of these uses are unsupported by the clinical literature—routine use in premature infants and routine adult uses are specifically highlighted as lacking demonstrated safety or effectiveness—and therefore are categorized in section IV as not medically necessary.

Coding and Thresholds

Referenced CPT CodesCPT

94799

Unlisted pulmonary service or procedure

HCPCSHCPCS

No codes listed

Referenced CPT Codes (informational)CPT

94799

Unlisted pulmonary service or procedure

HCPCS CodesHCPCS

No codes listed

inv-15: Oxygen Index (OI) — Initiation in term/near‑term newborns

Initiation threshold (term/near-term newborns)Oxygen Index (OI) > 25 for newborns ≥34 weeks gestational age

Weaning considerationConsider weaning when OI ≤ 10 after a 4–6 hour period of stability

Applies toNewborns ≥34 weeks gestational age at birth (see criteria I.A)

Documentation requiredCalculated OI must be documented (mean airway pressure × FiO2 × 100 ÷ PaO2) and evidence that conventional therapies failed

inv-16: Oxygen Index (OI) — numeric value emphasized in updates (25)

Updated numeric threshold

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and review requirements — document criteria and extended‑use review

Initiation and continuation of inhaled nitric oxide (iNO) require documentation that the member meets the policy's clinical criteria (see Initial and Continuation criteria). Extended administration beyond 72 hours requires secondary medical director review; requests should include documentation supporting criteria at initiation and ongoing response or weaning attempts.

Initiation/continuation requests must reference applicable initial (I) and continuation (III) criteria.
Extended administration >72 hours triggers secondary medical director review.

Prior Authorization

Follow clinical criteria and current CPT guidance (94799 referenced)

Submit prior authorization requests that follow the policy's clinical criteria and the current coding guidance. The policy references CPT 94799 (Unlisted pulmonary service or procedure) for informational purposes; inclusion of a code in the policy does not guarantee coverage.

Reference the policy criteria when selecting codes for authorization requests.

Background and Clinical Context

Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator delivered by inhalation that can improve pulmonary blood flow and oxygenation. The policy and referenced literature note that iNO can improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near‑term neonates with hypoxic respiratory failure, while evidence in other populations (preterm infants, adults with ARDS) is limited or shows only transient oxygenation benefits without mortality advantage.

Definitions and Clinical Measures

inv-30: Oxygen index (OI) definition — formula

FormulaOI = (mean airway pressure [cm H2O] × FiO2 × 100) ÷ PaO2 (mm Hg)

UnitsMean airway pressure in cm H2O; PaO2 in mm Hg; FiO2 as fraction (e.g., 0.21–1.0)

PurposeUsed to quantify severity of hypoxic respiratory failure and guide iNO initiation/weaning decisions

inv-31: Response to iNO trial — defined as increase in PaO2 ≥20 mmHg or ≥20% decrease in oxygen index

Response definitionIncrease in PaO2 ≥20 mmHg OR ≥20% decrease in oxygen index after an iNO trial

TimingA positive response generally occurs in less than 30 minutes

Policy Summary

PayerAmbetter Georgia

PolicyTherapeutic Utilization of Inhaled Nitric Oxide

Policy CodePolicy CP.MP.87

Change TypeMultiple material and editorial revisions (numeric threshold and indications added)

Effective Date

Next Review Date

SourceLink

On This Page

Added indication documented in revision history.

Administration route: The prior requirement that iNO be administered via endotracheal tube or tracheostomy was removed from section I.A.

Removes a previous administration-route requirement.

OI > 25 (numeric threshold emphasized in recent revision log)

Revision noteRevision log documents change from >20 to 25 under I.A.6

Use in criteriaThreshold is used as part of initial therapy criteria for term/near-term newborns

94799 is listed as an unlisted pulmonary service/procedure (informational).

Prior Authorization

Verify payer requirements and contract alignment before requesting authorization

Verify the member's contract and any payer-specific prior authorization requirements before submitting requests; this clinical policy guides coverage decisions but benefits administration is governed by the member's contract and applicable NCDs/LCDs for Medicare members.

Confirm plan-specific prior authorization rules and benefit limits prior to service.
For Medicare members, review applicable NCDs/LCDs; for Medicaid members, state Medicaid provisions take precedence if conflicting.

Step Therapy

Perioperative step‑down requirement — begin alternative vasodilator therapy during iNO

For perioperative iNO use in children/infants ≥34 weeks GA, initiation of alternative vasodilator therapy (e.g., sildenafil) must be started during iNO administration with intent to wean or discontinue iNO as part of the perioperative management plan.

Perioperative indications require documentation that alternative vasodilator therapy was initiated during iNO with intent to wean/discontinue.
Applies to perioperative management in children/infants ≥34 weeks GA per criteria I.B.2.

Note

Step therapy (policy excerpts) — none specified; follow payer rules if present

The policy notes there are no explicit step therapy requirements in these excerpted sections; providers should not assume additional mandated step therapy beyond documented conventional therapy failure and perioperative alternative vasodilator initiation where applicable.

Routine documentation of failed conventional therapies is required for initial approvals (e.g., mechanical ventilation, high FiO2, HFV, alkalosis induction).
If a plan imposes step‑therapy, follow that plan's requirements in addition to this policy's criteria.

Step Therapy

Step therapy — no additional step‑therapy requirements specified (per policy excerpts)

No explicit step‑therapy sequence beyond the perioperative step‑down requirement is specified in the policy excerpts; where step therapy is not stated, follow the policy criteria and payer prior authorization rules.

If the plan requires specific step‑therapy prior to authorization, follow that payer's process; the clinical policy itself does not list additional step therapy requirements.
Perioperative cases remain subject to the specific alternative vasodilator initiation requirement in I.B.2.

Documentation Required

Required clinical documentation — gestational age, PAH evidence, OI and response

Ensure the request package includes clinical evidence required by the policy: gestational age at birth, clinical or echocardiographic evidence of pulmonary arterial hypertension, prior use of maximal conventional respiratory therapies, calculated oxygen index (OI), and documented response to an iNO trial (PaO2 increase ≥20 mmHg or ≥20% decrease in OI) or weaning data.

Document gestational age at birth and whether the member meets age‑specific criteria (e.g., ≥34 weeks or reviewable <34 weeks).
Provide clinical or echocardiogram evidence of PAH and documentation of failed conventional therapies.
Include calculated OI and objective response data (up to 40 ppm trial response definition) or evidence of weaning protocol initiation.

Billing Rule

Billing and coding documentation — cite current CPT guidance and map to criteria

When submitting claims and authorization requests, reference current CPT guidance and include policy criteria rationale; the policy lists 94799 as an informational, unlisted pulmonary service — include narrative documentation tying the billed codes to the covered clinical criteria.

CPT inclusion/exclusion in the policy does not guarantee coverage; reference up‑to‑date coding sources before claim submission.
Provide clinical justification in the request that maps to the policy's criteria to reduce coding‑related denials.

Documentation Required

Medical necessity documentation — align clinical rationale with policy and standards

Document medical necessity consistent with generally accepted standards of practice and the evidence‑based guidelines cited in the policy; include the clinical rationale demonstrating that treatment meets the policy's specific criteria rather than relying on the policy as a substitute for clinical judgment.

Include objective measures (OI, PaO2 changes) and supportive clinical notes showing failure of conventional therapies.
Note: policy guides medical necessity determinations but does not replace provider clinical judgment.

Denial Risk

Denial triggers — not medically necessary indications

Requests for iNO for indications listed as not medically necessary in the policy (including acute bronchiolitis, bronchopulmonary dysplasia, most congenital diaphragmatic hernia except bridge‑to‑repair, acute respiratory distress except specified COVID‑19 rescue use, acute lung injury, adult post‑op cardiac surgery, and vaso‑occlusive crises in sickle cell disease) are subject to denial as safety and effectiveness have not been established.

Confirm the indication matches a covered criterion in sections I–III; if it falls under section IV exclusions, anticipate denial.
If claiming bridge‑to‑repair for CDH or COVID‑19 rescue ARDS, include documentation that meets the specific covered conditions.

Denial Risk

Coding and criteria‑related denial risks — codes and criteria may not guarantee coverage

Inclusion or exclusion of CPT codes in this policy does not guarantee payment; providers should check the most current coding guidance and be aware that numeric changes to criteria (e.g., OI threshold change to >25) or removal of prior administration‑route language can affect authorization outcomes.

Verify code applicability and payer coding edits prior to submission.
Be aware that policy revisions (OI threshold to >25, removed administration‑route requirement) may change authorization expectations.

Note

Contract and payer alignment — confirm coverage terms and applicable NCDs/LCDs

Claims or authorizations inconsistent with the member's contract may be denied; providers must align services with contractual terms and review state Medicaid provisions, Medicare NCDs/LCDs, and plan‑level policies as these take precedence where applicable.

Confirm contract coverage and any state Medicaid manual provisions that supersede this clinical policy.
For Medicare, review applicable NCDs and LCDs before applying this policy's criteria.

Trial dosing context

Response assessed during up to 40 ppm trial (recommended starting 20 ppm for term infants)

inv-32: iNO — shorthand definition: inhaled nitric oxide referenced in policy and citations

ShorthandiNO = inhaled nitric oxide (selective pulmonary vasodilator)

Role in policyReferenced throughout policy as the therapy under evaluation for neonatal, pediatric, and adult indications

Common abbreviationReferred to as 'iNO' in criteria, treatment regimen, and references

inv-33: inhaled nitric oxide (iNO) — additional definitional note about mechanism and studied populations

MechanismA selective pulmonary vasodilator delivered by inhalation that can improve pulmonary hemodynamics and oxygenation

Studied populationsEvaluated in term and near-term neonates, preterm infants (evidence inconclusive), pediatric patients, and adults with ARDS

Evidence considerationsShort-term oxygenation improvement demonstrated; mortality benefit not shown in adult ARDS and risks exist in preterm infants (e.g., intracranial hemorrhage)