This policy addresses nasal surgery for the treatment of obstructive sleep apnea and includes the use of radiofrequency ablation of nasal turbinates for nasal obstruction with or without the existence of OSA.

Note: For information related to other technologies utilized in the diagnosis and management of sleep-related disorders, please see:

• MED.00002 Diagnosis of Sleep Disorders;
• MED.00054 Treatment for Obstructive Sleep Apnea in Adults;
• Clinical UM Guideline CG-MED-01 Polysomnography Studies in Adults and Children;
• Clinical UM Guideline CG-DME-27 Non-invasive Positive Pressure Respiratory Assist Devices (BiPAP®).

Not Medically Necessary:

Nasal surgery employing any technique is considered not medically necessary for the treatment of snoring, as snoring, in and of itself, is not considered to be a medical condition or illness requiring treatment. Rather, it may be considered a social nuisance.

Investigational/Not Medically Necessary:

Nasal surgery employing any technique, including nasal valve surgery, septoplasty, turbinectomy, polypectomy and laser or radiofrequency ablation (volumetric tissue reduction) of the nasal turbinates is considered investigational/not medically necessary for the treatment of obstructive sleep apnea and other sleep related breathing disorders.

Radiofrequency ablation (volumetric tissue reduction) of nasal turbinates is considered investigational/not medically necessary for chronic nasal obstruction due to hypertrophy of the inferior turbinate.
 

Radiofrequency Ablation for Chronic Nasal Obstruction

The published literature consists of relatively few studies with mostly small numbers of patients. Although most reported subjective improvements in nasal obstructive symptoms following radiofrequency ablation, placebo- controlled groups were not included in most reports, and very few studies reported objective post-procedure measurements such as nasal resistance. There were conflicting data regarding changes in nasal resistance in the studies that did report on this, some showing improvement, others not. Generally, no long-term outcomes reporting was identified. One small placebo-controlled trial of 32 patients randomized to radiofrequency ablation of the inferior nasal turbinate versus placebo (sham) treatment revealed subjective improvement in both groups (a significant placebo effect was noted), but the amount of improvement in the severity of obstruction and overall ability to breathe was better in the treatment group compared with placebo.  No objective measurements were made however, the follow-up period was short (6-months), and the authors conclude that the long-term efficacy is still unclear. The National Institute for Clinical Excellence, Interventional Procedures Advisory Committee (an advisory group to the National Health Service in the UK) stated in September 2003 that the current evidence for the safety and efficacy of radiofrequency volumetric tissue reduction for turbinate hypertrophy was inadequate to support its use outside of a research situation. Larger placebo-controlled studies with longer follow up will be needed to validate the effectiveness of radiofrequency ablation of hypertrophied inferior nasal turbinates for chronic nasal obstruction.

Nasal Surgery for Obstructive Sleep Apnea

Studies suggest stimulation of receptors in the nasal airway improves muscle tone in the oropharynx, and increased nasal resistance results in increased negative intraluminal pressure, causing an increased tendency for the soft tissues of the upper airway (soft palate and pharyngeal walls) to collapse. In addition, nasal obstruction may lead to mouth breathing, and mouth opening, in turn, results in inferior movement of the mandible with associated decrease in pharyngeal diameter. The base of the tongue may also fall backwards reducing the posterior pharyngeal space. The rationale for nasal surgery is to improve nasal patency re-establishing physiological breathing and minimizing oral breathing during sleep; also to reduce nasal resistance and improve the negative intraluminal pressure which generates upper airway collapse.

However, studies have not demonstrated that reducing nasal obstruction and resistance from various causes and using various techniques (e.g., septoplasty, turbinectomy, polypectomy, radiofrequency ablation of inferior nasal turbinate) correlates with a significant reduction in objective obstructive sleep apnea indicators, such as Apnea-Hypopnea Index or nocturnal oxygen desaturation. Although some case reports have suggested that surgical correction of nasal obstruction may improve subjective daytime complaints in patients with obstructive sleep apnea, studies in general have been flawed by relatively small numbers of patients, the fact that nasal surgery is often performed in association with other surgical procedures, and lack of objective data regarding nasal resistance and obstructive sleep apnea diagnostic variables.

In their June 2003 review article, Chen, W. and Kushida, C.A., concluded that the exact role obstructed nasal breathing plays in the pathogenesis of obstructive sleep apnea type sleep disorders remains presumptive, and robust clinical studies to evaluate the contribution of nasal function remain elusive. More stringently controlled studies are needed. A review by Rappai, M. et al. concluded that, to date, there are no compelling data to demonstrate causality between nasal obstruction and persistent sleep disordered breathing. They point out that most of the studies reviewed in their December 2003 review article are short term, or only examined subjective outcomes to evaluate the effect on sleep disordered breathing. Clearly, further studies are needed to prove specific causality.

Nasal surgery for obstructive sleep apnea (OSA)

It has been postulated that increased nasal resistance may contribute to, or be causative, in sleep related breathing disorders such as obstructive sleep apnea. Nasal procedures that have been performed for the treatment of OSA include the following:

• Nasal valve surgery; This involves the slit-like opening formed by the septum, the caudal end of the upper lateral nasal cartilage, the soft tissue overlying the piriform aperture, the floor of the nose, and the head of the inferior turbinate. Loss of stability of the lateral nasal wall with subsequent collapse can occur at the level of the nasal valve and may result from nasal muscle dysfunction (e.g. from facial nerve palsy) or loss of skeletal support resulting from prior surgery. This collapse may be surgically corrected. 
• Septal surgery or septoplasty to straighten and thin a deviated or otherwise abnormal nasal septum (using several different techniques);
• Surgery to correct nasal turbinate hypertrophy or deformity (turbinectomy); This may involve the use of laser or radiofrequency ablation as an alternative to turbinectomy. 
• Nasal polypectomy.

Radiofrequency ablation for chronic nasal obstruction with or without OSA

Chronic nasal obstruction together with increased nasal resistance to airflow may be associated with inferior nasal turbinate hypertrophy. Some investigators have also postulated that increased nasal resistance may contribute to, or even be causative in, sleep related breathing disorders such as obstructive sleep apnea. Radiofrequency ablation (or volumetric tissue reduction) of the inferior nasal turbinate has been investigated as an alternative to established surgical treatments, such as turbinectomy, submucous resection, or electrocautery, in patients who are not controlled on medical therapy with decongestants, antihistamines, or topical steroids and in whom the nasal obstruction is thought to be caused by inferior nasal turbinate hypertrophy.

The procedure can be performed on an outpatient basis and under local anesthesia. A needle electrode is placed into the anterior inferior turbinate, and radiofrequency energy is delivered. The resultant lesion produces scarring and contraction of soft tissue, thereby reducing the volume of the turbinate and associated obstruction. The “Somnoplasty” system has received FDA approval for volumetric reduction of the nasal turbinates in patients with chronic obstructive congestion.

Chronic: persisting over a long period of time.

Nasal turbinates: the scroll-like bony plates with curved margins on the lateral wall of the nasal cavity.

Sleep apnea: temporary stoppage of breathing during sleep, often resulting in daytime sleepiness.

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When Services are Not Medically Necessary:

CPT

ICD-9 Diagnosis 

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above, for the diagnoses listed below; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

ICD-9 Diagnosis

Peer Reviewed Publications:

1. Bäck LJ, et al. Submucosal bipolar radiofrequency thermal ablation of inferior turbinates: a long term follow up with subjective and objective assessment. Laryngoscope. 2002; 112(10):1806-12.
2. Chen W, Kushida, CA. Nasal obstruction in sleep disordered breathing: Review article. Otolaryngolic Clinics of North America. 2003; 36(3):437-60. 
3. Friedman M, et al. Effect of improved nasal breathing on obstructive sleep apnea. Otolaryngol.Head Neck Surg. 2000; 122(1):71-4.
4. Masood A, Phillips B. Radiofrequency ablation for sleep disordered breathing. Current Opinion Pulmonary Medicine. 2001; 7(6):404-6. 
5. Mirza N, Lanza DC. The nasal airway and obstructed breathing during sleep. Otolaryngolic Clinics of North America. 1999; 32(2). 
6. Neace JM, Radiofrequncy treatment of turbinate hypertrophy, a randomized, blinded, placebo controlled clinical trial. Oto Larygnl Head Neck Surg. 2004; 130(3): 291-9.
7. Olson EJ, Park JG, Morgenthaler TI.  Obstructive aleep apnea-hypopnea syndrome.  Prim Care Clin Office Pract. 2005; 32:329-59.
8. Rappai M, et al. The nose and sleep disordered breathing. What we know and what we do not know. Chest. 2003; 124(6). 
9. Rhee CS, et al. Changes of nasal function after temperature-controlled radiofrequency tissue volume reduction for the turbinate. Laryngoscope. 2001; 111(1):153-8.
10. Sher AE, et al. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. An American Sleep Disorders Review, Sleep. 1995; 18(8):659-66. 
11. Stewart MG, Smith TL, Weaver EM, et al.  Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study.  Otolaryngol Head Neck Surg. 2004; 130(3):283-90.
12. Stuck BA, Sauter A, Hormann K, et al.  Radiofrequency surgery of the soft palate in the treatment of snoring.  A placebo controlled trial.  Sleep. 2005; 28(7):847-50.
13. Troell RJ.  Radiofrequency techniques in the treatment of sleep disordered breathing.  Otolaryngol Clin N Am. 2003; 36:473-93.
14. Verse T, et al. Effect of nasal surgery on sleep-related breathing disorders. Laryngoscope. January 1, 2002; 112(1): 64-8.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Otolaryngology- Head and neck surgery.  Available at:  http://www.entnet.org. Accessed on:  July 18, 2006.
2. American Academy of Sleep Medicine (AASM).  Practice parameters for the treatment of obstructive sleep apnea in adults:  The efficacy of surgical modifications of the upper airway.  Sleep.  1996; 19:152-55.
3. Blue Cross Blue Shield Association.  TEC Assessment: Radiofrequency Volumetric Reduction of Palatal Tissues and Base of Tongue.  2000(15).  
4. Bridgman S, Dunn K, Ducharme F.  Surgery for obstructive apnea.  The Cochrane Review.  Issue 3, 2004.
5. ClinicalTrials.gov. Randomized Controlled Trial of TCRFVR and LAUP in snorers.  Completed: March 2004. Available at:  http://clinicaltrials.gov/show/NCT00202943.  Accessed on:  July 18, 2006.
6. National Institute for Clinical Excellence (NICE). Interventional Procedures Consultation Document. Radiofrequency volumetric tissue reduction for turbinate hypertrophy. September 2003. Available at: http://www.nice.org.UK/article.asp?a=83802. Accessed on:  July 18, 2006. 
7. Hayes, Inc.  Hayes Medical Technology Directory.  Radiofrequency Tissue Volume Reduction (RFTVR) for the Treatment of Upper Airway Obstruction.  Lansdale, PA: Hayes, Inc; January 2006.
8. Hayes, Inc.  Hayes Medical Technology Directory.  Sleep apnea treatment, surgical. Lansdale, PA: Hayes, Inc; September 1999.  Search updated: September 13, 2005.
9. Institute for Clinical Systems Improvement (ICSI).  Health Care guideline:  Diagnosis and Treatment of Obstructive Sleep Apnea.  March 2005.  Available at: http://www.icsi.org/.  Accessed on:  July 18, 2006.

1. American Academy of Sleep Medicine (AASM).  Available at: http://www.aasmnet.org.  Accessed on:  July 18, 2006.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association