Nitric Oxide Therapy - Inhaled
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This policy governs Moda Health medical-necessity coverage and prior authorization for inhaled nitric oxide (INO) therapy, including approved neonatal treatment, pulmonary vasoreactivity assessment, and postoperative management in children with congenital heart disease. It applies to providers requesting INO therapy for Moda Health members.
The hypoxic respiratory failure criterion for term and near-term infants was clarified to require a gestational age of 34 weeks or greater.
Medical Necessity and Coverage Criteria
Medically necessary covered indications
INO therapy is medically necessary when at least one of the following covered indications applies:
At least one covered indication
Hypoxic respiratory failure in a term or near-term infant
Neonatal eligibility requirements
- Gestational age: The infant has a gestational age of 34 weeks or greater.>=34 weeks
- No congenital diaphragmatic hernia: Congenital diaphragmatic hernia is absent.Absent
- Conventional therapy failure or inability to use conventional therapy: The infant has failed, has a contraindication to, or cannot tolerate conventional therapy, or conventional therapy is expected to fail.
Conventional therapy includes high-frequency ventilation, high concentrations of oxygen, hyperventilation, alkalosis induction, neuromuscular blockade, or sedation.
- Diagnostic pulmonary vasoreactivity assessment: INO is used diagnostically to assess pulmonary vasoreactivity in a patient with pulmonary hypertension.
- Postoperative pulmonary hypertensive crisis: INO is used for postoperative management of pulmonary hypertensive crisis in an infant or child with congenital heart disease.
Duration and medical-director review
Duration limitation:
Requests for INO therapy beyond 14 days must be referred to the medical director.
Other indications
Indications not specifically listed as medically necessary are not covered as medically necessary:
The policy states that these uses have not been identified as widely used and generally accepted in nationally recognized peer-reviewed medical literature.
Congenital diaphragmatic hernia is excluded from the neonatal hypoxic respiratory failure criterion. For coverage under this criterion, the infant must have hypoxic respiratory failure, be term or near-term with a gestational age of 34 weeks or greater, and have no congenital diaphragmatic hernia.
Coding and Coverage Parameters
| 94002 | Ventilation assist and management, initiation of pressure or volume preset ventilators for assisted or controlled breathing; hospital inpatient/observation, initial day |
| 94003 | Ventilation assist and management, initiation of pressure or volume preset ventilators for assisted or controlled breathing; hospital inpatient/observation, each subsequent day |
| 94004 | Ventilation assist and management, initiation of pressure or volume preset ventilators for assisted or controlled breathing; nursing facility, per day |
| I27.0 | Primary pulmonary hypertension |
| I27.1 | Kyphoscoliotic heart disease |
| I27.2 | Other secondary pulmonary hypertension |
| I27.82 | Chronic pulmonary embolism |
| I27.89 | Other specified pulmonary heart diseases |
| I97.3 | Postprocedural hypertension |
| P07.36 | Preterm newborn, gestational age 33 completed weeks |
| P07.37 | Preterm newborn, gestational age 34 completed weeks |
| P07.38 | Preterm newborn, gestational age 35 completed weeks |
| P07.39 | Preterm newborn, gestational age 36 completed weeks |
Authorization and Documentation Requirements
Prior Authorization Submission Required
Prior authorization is required for INO therapy. Submit the ordering specialist's chart notes, including the history and physical, along with the member's treatment history and proposed treatment plan.
- Ordering specialist chart notes, including history and physical
- Member's treatment history
- Proposed treatment plan
Medical-Director Review for Extended Therapy
INO therapy is considered medically necessary for no longer than 14 days after oxygen desaturation has resolved. Requests extending beyond 14 days must be referred to the medical director for review.
- Refer extended therapy requests to the medical director.
Ordering Specialist Chart Notes Required
Include chart notes from the ordering specialist with the prior authorization request, including the member's history and physical.
Treatment History Required
Submit the member's relevant treatment history with the prior authorization request.
Treatment Plan Required
Submit the proposed treatment plan with the prior authorization request.
Unlisted Indications Are Experimental
INO therapy for indications other than the covered indications is considered experimental and investigational and is not covered under this policy.
- Covered indications: hypoxic respiratory failure in term and near-term infants meeting criteria; diagnostic pulmonary vasoreactivity assessment in pulmonary hypertension; and postoperative management of pulmonary hypertensive crisis in infants and children with congenital heart disease.
Neonatal Eligibility Criteria Must Be Met
Neonatal eligibility criteria must be met for coverage of INO therapy for hypoxic respiratory failure. Coverage is not available when the infant is less than 34 weeks' gestational age, has a congenital diaphragmatic hernia, or does not meet the required conventional-therapy criteria.
- Gestational age must be 34 weeks or greater.
- There must be no congenital diaphragmatic hernia.
- There must be failure, contraindication, intolerance, or expected failure of conventional therapy.
Extended Therapy Requires Medical-Director Review
Requests to continue INO therapy for more than 14 days after oxygen desaturation has resolved require referral to the medical director for review.
- Therapy beyond the 14-day limit is not automatically covered.
Clinical Background
Inhaled nitric oxide (INO) is a selective pulmonary vasodilator used to improve gas exchange and manage pulmonary hypertension. The therapy may be used with ventilatory support in neonatal patients, including pulmonary hypertension associated with meconium aspiration and related birth defects. The policy also recognizes diagnostic use to assess pulmonary vasoreactivity and postoperative treatment of pulmonary hypertensive crisis in infants and children with congenital heart disease.
Key Term
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