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Medical Policy: 07.01.44
Original Effective Date: November 2008
Reviewed: April 2012
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Obstructive sleep apnea syndrome (OSA) is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. Air enters the nose, mouth and throat as it passes to the lungs. Normally the throat is flexible and tends to collapse inward with breathing. Muscles work to oppose the collapse and keep the airway open. Interference or defects in this process cause air turbulence. If tissues in the back of the throat collapse causing momentary blockage, apnea occurs. Breathing stops temporarily. The patient is usually unaware of it, but sometimes may awaken gasping for breath. When interference is incomplete causing continuous, slow, shallow breathing , obstructive hypopnea occurs. Oxygen in the blood is reduced due to the apnea, and eventually the lack of oxygen activates the lungs to suck in air. In patients with OSA, the normal pharyngeal narrowing is accentuated by anatomic factors, such as a short, fat"bull" neck, elongated palate and uvula, or large tonsillar pillars with redundant lateral pharyngeal wall mucosa. Furthermore, OSA may be associated with a wide variety of craniofacial abnormalities, including micrognathia, retrognathia, or maxillary hypoplasia. In addition, OSA is associated with obesity. Obstruction anywhere along the upper airway can result in apnea. Therefore, OSA is associated with a heterogeneous group of anatomic variants producing obstruction.
The hallmark clinical symptom of OSA is excessive snoring. The snoring abruptly ceases during the apneic episodes and during the brief period of patient arousal and then resumes when the patient again falls asleep. Sleep fragmentation associated with repeated arousal during sleep can lead to impairment of daytime activity. For example, patients with OSA-associated daytime somnolence are thought to be at higher risk for accidents involving motorized vehicles, i.e., cars, trucks, or heavy equipment. OSA in children may result in neurocognitive impairment and behavioral problems. In addition, OSA affects the cardiovascular and pulmonary systems. For example, apnea leads to periods of hypoxia, alveolar hypoventilation, hypercapnia, and acidosis. This in turn can cause systemic hypertension, cardiac arrhythmias, and cor pulmonale. Systemic hypertension is common in patients with OSA. Severe OSA is also associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile accidents related to daytime sleepiness.
Upper airway resistance syndrome (UARS) is a variant of OSA that is characterized by a partial collapse of the airway resulting in increased resistance to airflow. The increased respiratory effort required results in multiple sleep fragmentations as measured by very short alpha electroencephalographic (EEG) arousals. Snoring may not be a feature of UARS. The resistance to airflow is typically subtle and does not result in apneic or hypopneic events. However, it does result in increasingly negative intrathoracic pressure during inspiration, which can be measured using an esophageal manometer as an adjunct to a polysomnogram. Therefore, this diagnosis rests on polysomnographic documentation of >10 EEG arousals per hour of sleep correlated with episodes of reduced intrathoracic pressures.
Nonsurgical treatment for OSA or UARS includes continuous positive airway pressure (CPAP) or orthodontic repositioning devices, which are addressed in policy number 07.01.21, Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome and Upper Airway Resistance Syndrome. Traditional surgeries include uvulopalatopharyngoplasty (UPPP) and a variety of maxillofacial surgeries such as mandibular-maxillary advancement (MMA). These surgeries are considered separately in policy number 07.01.43 Surgical Management of Obstructive Sleep Apnea Syndrome. This policy addresses minimally invasive approaches to the treatment of snoring and OSA: laser-assisted uvulopalatoplasty (LAUP); radiofrequency ablation of palatal tissues and the tongue; palatal stiffening procedures; and the Repose™ Bone Screw System.
The following treatments of OSA and UARS are available:
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The LAUP is an outpatient alternative that has been proposed as a treatment of snoring with or without associated OSA. In this procedure, superficial palatal tissues are sequentially reshaped using a carbon dioxide laser. The extent of the surgery is typically different than standard UPPP, since only part of the uvula and associated soft-palate tissues are reshaped. The procedure, as initially described, does not remove or alter tonsils or lateral pharyngeal wall tissues. The patient undergoes from 3 to 7 sessions at 3- to 4-week intervals. One purported advantage of LAUP is that the amount of tissue ablated can be titrated such that the treatment can be discontinued once snoring is eliminated. The LAUP cannot be considered an equivalent procedure to the standard UPPP, with the laser simply representing a surgical tool that the physician may opt to use. LAUP is considered a unique procedure, raising unique issues of safety and, particularly, effectiveness.
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Radiofrequency ablation of the soft palate is similar in concept to LAUP, although a different energy source is used, and radiofrequency is used to produce thermal lesions within the tissues, rather than using a laser to ablate the tissue surface, which may be painful. For this reason, radiofrequency ablation appears to be growing in popularity as an alternative to LAUP. The Somnoplasty device is a device approved by the U.S. Food and Drug Administration (FDA) for radiofrequency ablation of palatal tissues for simple snoring and for the base of the tongue for OSA. In some situations, radiofrequency of the soft palate and base of tongue are performed together as a multilevel procedure.
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Palatal stiffening procedures include a cautery-assisted palatal stiffening operation (CAPSO) and insertion of palatal implants. The CAPSO procedure uses cautery to induce a midline palatal scar designed to stiffen the soft palate to eliminate excessive snoring. The Pillar™ Palatal Implant System (Restore Medical, St. Paul, MN) is an implantable device that has been cleared by the FDA 510(k) process. The device is a cylindrical-shaped segment of braided polyester filaments that is permanently implanted submucosally in the soft palate. The labeled indication of the device is as follows:
“The Pillar™ Palatal Implant System is intended for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (obstructive sleep apnea).”
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Prior Approval:
Not applicable
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Policy:
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Radiofrequency volumetric tissue reduction (Somnoplasty™, Coblation®) of the tongue, with or without radiofrequency reduction of the palatal tissues, is considered investigational for upper airway resistance syndrome or OSA.
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Laser-assisted palatoplasty (LAUP) or radiofrequency volumetric tissue reduction of the palatal tissues is considered not medically necessary in the treatment of snoring* alone, and is considered investigational as a treatment for upper airway resistance syndrome or OSA.
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Palatal stiffening procedures, including but not limited to, cautery-assisted palatal stiffening operation (CAPSO), and the implantation of palatal implants (The Pillar® Palatal Implant System), are considered not medically necessary in the treatment of snoring* alone, and are considered investigational as a treatment for upper airway resistance syndrome or OSA.
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Repose™ System, the suspension of the tongue base using a bone screw, is considered investigational in the treatment of upper airway resistance syndrome or OSA.
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*Simple snoring in the absence of documented obstructive sleep apnea is not considered a medical condition; therefore, any surgical intervention, such as LAUP, radiofrequency volumetric tissue reduction of the palate, palatal stiffening procedures, or the Repose™ System is considered not medically necessary.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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S2080 Laser-assisted uvulopalatoplasty (LAUP)
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41530 Submucosal radiofrequency tissue volume reduction of tongue base, one or more sites, per session (ie, for treatment of obstructive sleep apnea syndrome)
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There are no specific codes available for radiofrequency ablation of palate (Somnoplasty™), the Repose™ System, the Pillar® Palatal Implant system, and the CAPSO report CPT code 42299; unlisted procedure for palate, uvula.
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Selected References:
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The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
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A review of the medical literature and recommendations from the Medical Policy Advisory Council (MPAC), which assists Wellmark’s medical directors in the development of medical policies. MPAC is comprised of practicing physicians from Iowa and South Dakota.
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Mair EA, Day RH. Cautery-assisted palatal stiffening operation. Otolaryngology Head and Neck Surgery 2000; 122:547-555.
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DeRowe A, Gunther E, et al. Tongue-based suspension with a soft tissue to bone anchor for obstructive sleep apnea: Preliminary clinical results of a new minimally invasive technique. Otolaryngology Head and Neck Surgery 2000; 122:100-103.
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Woodson BT. Surgical approaches to obstructive sleep apnea. Current Opinion in Pulmonary Medicine 1998;4:344-350.
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Fukuse T, Satoda N, Hijiya K, Fujinaga T. Importance of a comprehensive geriatric assessment in prediction of complications following thoracic surgery in elderly patients. Chest. 2005 Mar;127(3):886-91.
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Goode, RL. Success and Failure in Treatment of Sleep Apnea Patients. Otolaryngologic Clinics of North America 2007 Aug 01; 40(4): 891-901.
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Goode, RL. Success and Failure in Treatment of Sleep Apnea Patients. Otolaryngologic Clinics of North America 2007 Aug 01; 40(4): 891-901.
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Epstein LJ, KristoD, Strollo PJ Jr. Friedman N, Malortra A, Patil SP, rama K, Rogers R, Schwab RJ, Weaver EM, Weinsteing MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.
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ECRI Institute. Palatal implants for obstructive sleep apnea. Plymouth Meeting (PA): ECRI Institute; 2010 Sept 15. 8p. [ECRI hotline response]. Also available: http://www.ecri.org.
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ECRI Institute. Radiofrequency ablation (somnoplasty) for obstructive sleep apnea or snoring. Plymouth Meeting (PA): ECRI Institute; 2010 Dec 08. 11p. [ECRI hotline response]. Also available: http://www.ecri.org.
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ECRI Institute. Palatal Implants for the Treatment of Obstructive Sleep Apnea. Plymouth Meeting (PA): ECRI Institute; 2011 November 10. [Hotline Response]. Also available at: http://www.ecri.org.
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ECRI Institute. Laser-assisted Uvulopalatoplasty for Treating Obstructive Sleep Apnea and Upper Airway Resistance Syndrome. Plymouth Meeting (PA):ECRI Institute; 2011 November 16. [ECRI Institute’s Health Technology Assessment Information Service]. Also available at: http://www.ecri.org.
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ECRI Institute. Radiofrequency Ablation for Treating Obstructive Sleep Apnea or Snoring. Plymouth Meeting (PA):ECRI Institute;2011 November 17. [Hotline Response] Also available at: http://www.ecri.org.
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Policy History:
Date Reason Action
May 2011 Annual review Policy renewed
April 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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and, therefore, cannot guarantee any results or outcomes.
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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