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Date Printed: April 22, 2018: 05:40 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

07-00007-12

Original Effective Date: 04/15/01

Reviewed: 12/08/17

Revised: 12/15/17

Subject: Inhaled Nitric Oxide

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates      
           

DESCRIPTION:

Inhaled nitric oxide (INO) is a natural vasodilator and has been studied for a variety of types of respiratory failure. Most commonly, it is used as an initial treatment for neonates with hypoxic respiratory failure to improve oxygenation and reduce the need for invasive extracorporeal membrane oxygenation (ECMO). It is also proposed as a treatment for premature infants, critically ill children and adults with respiratory failure, as well as in the postoperative management of children undergoing repair of congenital heart disease and patients after lung transplantation to prevent or reduce reperfusion injury.

Hypoxic respiratory failure may result from respiratory distress syndrome, persistent pulmonary hypertension, meconium aspiration, pneumonia, or sepsis. Its treatment typically includes oxygen support, mechanical ventilation, induction of alkalosis, neuromuscular blockade, or sedation. INO is both a vasodilator and a mediator in many physiologic and pathologic processes. INO has also been proposed for use in preterm infants less than 34 weeks of gestation.

There are several potential uses for INO in surgery. One is the proposed use of INO to manage pulmonary hypertension after cardiac surgery in infants and children with congenital heart disease. In congenital heart disease patients, increased pulmonary blood flow can cause pulmonary hypertension. Cardiac surgery can restore the pulmonary vasculature to normal, but there is the potential for complications, including postoperative pulmonary hypertension, which can prevent weaning from ventilation and is associated with substantial morbidity and mortality. Another potential surgical application is use of INO in lung transplantation to prevent or reduce reperfusion injury.

Inhaled nitric oxide (INO) appears to be of greatest benefit in individuals for whom primary or secondary pulmonary hypertension is a component of hypoxic respiratory failure. The benefit of INO appears limited in term or near-term infants whose hypoxic respiratory failure is due to diaphragmatic hernia.

POSITION STATEMENT:

Inhaled nitric oxide meets the definition of medical necessity as a component of treatment for hypoxic respiratory failure in neonates born at more than 34 weeks of gestation.

Inhaled nitric oxide is considered experimental or investigational for all other indications, including but not limited to the conditions below, as data in published medical literature are inadequate to permit scientific conclusions on long-term and net health outcomes:

• Treatment of premature neonates born at less than or equal to 34 weeks of gestation with hypoxic respiratory failure

• Treatment of adults and children with acute hypoxemic respiratory failure

• Postoperative use in adults and children with congenital heart disease

• In lung transplantation, during and/or after graft reperfusion

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS code to report inhaled nitric oxide.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

Congenital diaphragmatic hernia (CDH): Herniation (bulging, looping) of the abdominal or retroperitoneal structures into the thorax, present at birth.

Hypoxic respiratory failure: A condition of under-oxygenation; an inadequate level of tissue oxygenation for cellular metabolism. Symptoms include dyspnea and tachypnea.

Hypoxemia: abnormally low arterial oxygen levels.

Meconium: A fetus or newborn’s first feces (a dark green mucous material); typically passed in the uterus during early pregnancy and again in the first few days after birth.

Meconium aspiration syndrome (MAS): Inhalation of meconium by the fetus or newborn, which may block the newborn’s airways right after birth. It can cause respiratory difficulty due to inflammation in the lungs after birth.

Pulmonary hypertension: High blood pressure in the arteries to the lungs. The blood vessels that carry blood from the heart to the lungs become hard and narrow, causing the heart to work harder to pump the blood. Over time, the heart weakens and cannot do its job, resulting in heart failure.

Neonatal respiratory distress syndrome (RDS): Condition of the newborn marked by dyspnea with cyanosis, often caused by a lack of surfactant in the lungs, or by genetic problems with lung development.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. American Academy of Pediatrics Policy Statement: Use of Inhaled Nitric Oxide (RE0009); August 2000.
  2. Askie LM, Ballard RA, et al. Inhaled nitric oxide in preterm infants: an individual-patient data meta-analysis of randomized trials. Pediatrics. 2011 Oct;128(4):729-39.
  3. Barst RJ, Channick R, Ivy D, Goldstein B. Clinical perspectives with long-term pulsed inhaled nitric oxide for the treatment of pulmonary arterial hypertension. Pulm Circ. 2012 Apr-Jun;2(2):139-47.
  4. Blue Cross Blue Shield Association Medical Policy Reference Manual. 8.01.37, Inhaled Nitric Oxide (May 2017).
  5. Blue Cross Blue Shield of Florida physician consultant, (03/14/01).
  6. Dorland’s Illustrated Medical Dictionary, 27th Edition.
  7. ECRI Health Technology Trends, “Latest trials unlikely to broaden use of nitric oxide therapy for premature infants”, (Oct. 2005).
  8. HCPCS Level II Coding (current edition).
  9. Kinsella JP, Steinhorn RH, Krishnan US, et al. Recommendations for the use of inhaled nitric oxide therapy in premature newborns with severe pulmonary hypertension. J Pediatr. Mar 2016;170:312-314.
  10. Konduri GG, Sokol GM, et al. Impact of early surfactant and inhaled nitric oxide therapies on outcomes in term/late preterm neonates with moderate hypoxic respiratory failure. J Perinatol. 2013 Dec;33(12):944-9.
  11. Kumar P. Use of inhaled nitric oxide in preterm infants. Pediatrics. 2014 Jan 1;133(1):164-70.
  12. Merck Manual. Acute Hypoxemic Respiratory Failure (AHRF, ARDS). Accessed at http://www.merckmanuals.com/professional/.
  13. Sokol GM, Konduri GG, Van Meurs KP. Inhaled nitric oxide therapy for pulmonary disorders of the term and preterm infant. Semin Perinatol. 2016 Oct;40(6):356-369.
  14. Soll RF. Inhaled nitric oxide for respiratory failure in preterm infants. Neonatology. 2012;102(4):251-3.
  15. U.S. National Library of Medicine. MedlinePlus Medical Encyclopedia. Diaphragmatic hernia; Meconium; Meconium aspiration syndrome; Pulmonary hypertension. Accessed at https://medlineplus.gov/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the Florida Blue Medical Policy & Coverage Committee on 12/08/17.

GUIDELINE UPDATE INFORMATION:

04/15/01

New Medical Coverage Guideline.

09/27/01

Medical Coverage Guideline reviewed.

01/01/02

HCPCS changes.

10/15/03

Scheduled review; no change in coverage statement.

01/15/06

Revision - additional reference added.

04/01/07

2nd Quarter HCPCS coding update; deleted S1025.

12/15/17

Medical Coverage Guideline returned to active status. Revised MCG title, description section, position statement, program exceptions, and definitions. Updated references.

Date Printed: April 22, 2018: 05:40 PM