This document addresses both non-surgical and surgical treatments for obstructive sleep apnea in adults, other than continuous positive airway pressure (CPAP) and related devices, (such as BiPAP). This includes oral appliances, uvulopalatopharyngoplasty (UPPP), hyoid myotomy and jaw realignment surgery, various laser and radiofrequency surgical procedures, and surgical implants, and other more specialized procedures.

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;
• SURG.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) including Radiofrequency Ablation of Nasal Turbinates for Nasal Obstruction with or without OSA;
• Clinical UM Guideline CG-DME-32 Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea in Adults and Children, and Related Devices for the Treatment of 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^®).

Medically Necessary:

The treatment of obstructive sleep apnea (OSA) in adults is considered medically necessary for patients who meet either of the following criteria on polysomnography:

1. Apnea Hypopnea Index (AHI) or a Respiratory Disturbance Index (RDI) greater than or equal to 15 events per hour; OR
2. AHI (or RDI) greater than or equal to 5, and less than 15 events per hour with documentation demonstrating any of the following symptoms:
   • Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities; or
   • Impaired cognition or mood disorders; or
   • Hypertension; or
   • Ischemic heart disease or history of stroke; or
   • Cardiac arrhythmias, or
   • Pulmonary hypertension.

The AHI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of two hours of sleep recorded by polysomnography using actual recorded hours of sleep, (i.e., the AHI may not be extrapolated or projected).

Note: For the purposes of this document, the terms apnea hypopnea index (AHI) and respiratory disturbance index (RDI) are interchangeable, although they may differ slightly in clinical use; an AHI/RDI greater than 30 is consistent with severe obstructive sleep apnea.  In some cases, respiratory effort-related arousals (or RERAS) are included in the RDI value.  These RERA episodes represent EEG arousals associated with increased respiratory efforts but do not qualify as apneic or hypopneic episodes because of the absence of their defining air flow changes and/or levels of oxygen desaturation.

The following non-surgical treatment in adults is considered medically necessary:

Oral Appliances:

Custom-fitted and prefabricated oral appliances are considered medically necessary for OSA patients who meet the above medical necessity criteria.

(For information about treatment with CPAP, see Clinical UM Guideline CG-DME-32 Continuous Positive Airway Pressure [CPAP] for the Treatment of Obstructive Sleep Apnea in Adults and Children, and Related Devices for the Treatment of Obstructive Sleep Apnea in Adults.) 

Note: According to the medical literature, patients undergoing oral appliance treatment for OSA may also undergo dental rehabilitation.  Oral appliances and/or dental rehabilitation (dentures, bridgework, etc.) may not be a covered benefit under the benefit plan/certificate.  Therefore, it is important that the member understands his/her specific benefit inclusions/exclusions when making a decision regarding this treatment.

The following surgical treatments in adults are considered medically necessary: 

Uvulopalatopharyngoplasty (UPPP): 

Uvulopalatopharyngoplasty (UPPP) is considered medically necessary if ALL of the following (1-3) are present:

1. Documented obstructive sleep apnea with apnea hypopnea index (AHI) or respiratory disturbance index (RDI) meeting the following parameters:
   1. UPPP as sole procedure: with AHI (or RDI) >15 and <40, OR AHI/RDI 10-15 with one or more of the conditions listed below:
      • Hypertension; or
      • Cardiac arrhythmias predominately during sleep; or
      • Pulmonary hypertension; or
      • Documented ischemic heart disease; or
      • Impaired cognition or mood disorders; or
      • History of stroke; or
      • Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness Scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities.
        OR
   2. UPPP as part of a planned staged or combined surgery aimed at also relieving retrolingual obstruction, (e.g., genioglossal advancement, hyoid myotomy and suspension): AHI/RDI >15, OR AHI/RDI 10-15 with one or more of the conditions listed below:  
      • Hypertension; or
      • Cardiac arrhythmias predominately during sleep; or
      • Pulmonary hypertension; or
      • Documented ischemic heart disease; or
      • Impaired cognition or mood disorders; or
      • History of stroke; or
      • Excessive daytime sleepiness, as documented by either a score of greater than 10 on the Epworth Sleepiness Scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities. AND
2. CPAP (continuous positive airway pressure) has been tried with well-supported follow-up and clearly failed or is not tolerated.* AND
3. Pre-operative evaluation including fiberoptic endoscopy suggests retro-palatal narrowing is the primary source of airway obstruction if UPPP is the sole procedure or a contributing source of airway obstruction if part of a planned staged or combined surgery aimed at also relieving retrolingual obstruction.

Soft Tissue Reconstruction:

Hyoid myotomy and suspension, and/or mandibular osteotomy with genioglossus (tongue) advancement for the treatment of OSA is considered medically necessary for patients who have failed treatment with CPAP* and have demonstrated significant soft tissue and/or tongue base abnormalities with airway collapse.  Objective evidence of hypopharyngeal obstruction may be documented by either fiberoptic endoscopy or cephalometric radiographs.

 Jaw Realignment Surgery:

Jaw realignment surgery (i.e., maxillomandibular advancement) is considered medically necessary for patients who have failed treatment with CPAP* and either UPPP or genioglossus advancement and/or hyoid myotomy with suspension or both of these surgical procedures.

Jaw realignment surgery is considered medically necessary as a first line treatment for patients with a documented severe jaw/facial bony abnormality that contributes to OSA, including, but not limited to, craniofacial abnormalities, micrognathia, retrognathia or small retro-positioned jaw with associated overbite and small mouth.

Note: According to the medical literature, patients undergoing jaw realignment surgery also typically undergo orthodontic therapy to correct changes in occlusion associated with the surgery.  Orthodontic therapy (i.e., placement of orthodontic brackets and wires) may not be a covered benefit under the benefit plan/certificate.  Therefore, it is important that the member understands his/her specific benefit inclusions/exclusions when making a decision regarding this treatment. 

*Failed CPAP is defined as any of the following criteria documented in the medical record:

• Claustrophobia; or
• Inability to breathe through the nose; or
• Pain or discomfort; or
• Patient intolerance; or
• Patients at high pressures of CPAP (> 10 cm H2O) complaining of pressure discomfort.

 Not Medically Necessary:

UPPP as a sole procedure with AHI/RDI under 10 is considered not medically necessary.

The use of oral appliances except as specified above for the treatment of OSA is considered not medically necessary. 

Treatment of snoring without sleep apnea is considered not medically necessary, including, but not limited to the use of the following treatment methods:

1. UPPP; 
2. Oral appliances (e.g., Snore Guard);
3. Radiofrequency Volumetric Tissue Reduction (RFVTR) of the soft palate and/or the base of the tongue, including Somnoplasty^® and Coblation;^®
4. Laser-Assisted Uvulopalatoplasty (LAUP);
5. Cautery Assisted Palatal Stiffening Operation (CAPSO) or Palatal Implants. 

Investigational and Not Medically Necessary:

The use of Palatal implants is considered investigational and not medically necessary including, but not limited to:

1. Injection snoreplasty;
2. The Pillar^TM system.

Uvulopalatopharyngoplasty (UPPP) is considered investigational and not medically necessary for UARS (upper airway resistance syndrome).

Other treatments for OSA (excluding CPAP/related devices, such as BiPAP) are considered investigational and not medically necessary including, but not limited to, the following:

1. Cautery-assisted Palatal Stiffening Operation (CAPSO);
2. Electrosleep therapy;
3. Laser-Assisted Uvulopalatoplasty (LAUP);
4. Radiofrequency Volumetric Tissue Reduction (RFVTR) of the soft palate and/or the base of the tongue including Somnoplasty^® and Coblation;^® 
5. Nasal surgery; (See SURG.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) including Radiofrequency Ablation of Nasal Turbinates for Nasal Obstruction with or without OSA for further information.)
6. Transpalatal advancement pharyngoplasty;
7. The Repose^® System.

In 2009, a Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults was prepared by the Adult OSA Task Force of the American Academy of Sleep Medicine (AASM) (Epstein, 2009). According to the AASM (which was formerly known as the American Sleep Disorders Association), "This task force was assembled to produce a clinical guideline from a review of existing practice parameters and available literature. All existing evidence-based AASM practice parameters relevant to the evaluation and management of OSA in adults were incorporated into this guideline." The following is excerpted from this AASM document:

• This guideline does not apply to surgical therapy for primary snoring.
• Custom made oral appliances (OA) may improve upper airway patency during sleep by enlarging the upper airway and/or by decreasing upper airway collapsibility, (e.g., improving upper airway muscle tone). 
• Although not as efficacious as CPAP, oral appliances (OAs) are indicated for use in patients with mild to moderate OSA who prefer OAs to CPAP, or who do not respond to CPAP, are not appropriate candidates for CPAP, or who fail CPAP or behavioral measures, such as weight loss or sleep position change.
• Patients with severe OSA should have an initial trial of nasal CPAP because greater effectiveness has been shown with this intervention than with the use of OAs.
• Evaluation for primary surgical treatment can be considered in patients with mild OSA who have severe obstructing anatomy that is surgically correctible (e.g., tonsillar hypertrophy obstructing the pharyngeal airway).
• Upper airway surgery (including tonsillectomy and adenoidectomy, craniofacial operations, and tracheostomy) may also supersede use of OAs in patients for whom these operations are predicted to be highly effective in treating sleep apnea.
• Although the specifics of sleep apnea surgeries are beyond the scope of this guideline, surgical procedures may be considered as a secondary treatment for OSA when the outcome of PAP therapy is inadequate, such as when the patient is intolerant of PAP, or PAP therapy is unable to eliminate OSA.
• Surgery may also be considered as a secondary therapy when there is an inadequate treatment outcome with an OA, when the patient is intolerant of the OA, or the OA therapy provides unacceptable improvement of clinical outcomes of OSA.
• Surgery may also be considered as an adjunct therapy when obstructive anatomy or functional deficiencies compromise other therapies or to improve tolerance of other OSA treatments.
• Maxillary and mandibular advancement can improve polysomnography (PSG) parameters comparable to CPAP in the majority of patients.
• Most other sleep apnea surgeries are rarely curative for OSA but may improve clinical outcomes, (e.g., mortality, cardiovascular risk, motor vehicle accidents, function, quality of life, and symptoms).
• Laser-assisted uvulopalatoplasty is not recommended for the treatment of obstructive sleep apnea.  (AASM, 2009)

There is widespread agreement in the published studies of UPPP, as to the definition of "success" of the procedure. This is defined as a reduction in pre-operative AHI/RDI or Apnea index (AI) by at least 50% with a post UPPP AHI/RDI of < 20; or a post UPPP AI < 10. Using these definitions, a patient whose pre-operative AHI/RDI/AI is < 10 is already (by definition) "cured" of their obstructive sleep apnea and is, therefore, not an appropriate candidate for UPPP. Furthermore, there is no published literature that supports the value of UPPP for this group of patients.

There is also recognition in the literature that UPPP, when performed as the sole procedure, is less likely to be a success when severe obstructive sleep apnea is present preoperatively. The American Academy of Sleep Medicine defines "severe" as an AHI/RDI > 30. There is evidence that UPPP, when performed for patients with an AHI/RDI > 40, is unsuccessful in the vast majority of cases (Friedman 2005; Millman 2000; Janson 1997). This may, in part, be related to the presence of unrecognized coexistent hypopharyngeal obstruction in patients with severe obstructive sleep apnea that could not be expected to be adequately relieved by UPPP alone, which addresses only velopharyngeal obstruction. In a retrospective chart review of 134 patients having undergone UPPP alone, those whose preoperative AHI was > 40 failed to have a successful result, (defined as a 50% reduction in AHI with postoperative AHI< 20) in 73.5% cases. That is to say the success rate was only 26.5% (Friedman, 2005).

Hyoid myotomy and suspension and mandibular osteotomy with genioglossus advancement have been demonstrated in multiple case series studies to provide significant relief of symptoms for patients suffering from OSA where hypopharyngeal (retrolingual) obstruction during sleep is a significant factor. These soft tissue reconstructive procedures have been shown to successfully alter the anatomy of OSA patients sufficiently to prevent upper airway collapse. Not all patients are appropriate for this procedure. Careful evaluation of a patient's upper airway anatomy should take place prior to consideration of this procedure. As with UPPP, hyoid myotomy and suspension and mandibular osteotomy with genioglossus advancement should not be used as first line treatments, and trials of conservative therapies, such as CPAP, should be attempted first. Hyoid myotomy and suspension and mandibular osteotomy with genioglossus advancement may be performed, along with UPPP, in selected patients where both velopharyngeal (retropalatal) and hypopharyngeal (retrolingual) obstruction during sleep are thought to occur.

The use of jaw realignment surgery in patients with OSA who are unresponsive to other therapies has been demonstrated to be an effective treatment. While the results of this procedure have been shown to significantly improve the symptoms of OSA, jaw realignment surgery involves extensive jaw reconstruction. Several articles in the peer-reviewed literature have proposed a stepwise approach to OSA therapy that requires the use of other conservative and surgical interventions, mainly CPAP and UPPP, prior to consideration of jaw realignment surgery. This conservative approach is appropriate in all but the most extenuating circumstances involving severe maxillofacial malformations related to OSA. The literature on this procedure indicates that success varies with the experience of the surgeon and the facility, and care should be taken in their selection.

At this time, there is not adequate evidence in the medical literature demonstrating the efficacy of radiofrequency ablation techniques for the treatment of OSA. Radiofrequency Volumetric Tissue Reduction (RFVTR) involving the base of the tongue and soft palate, including two procedures marketed as Somnoplasty^® and Coblation,^® have been described in the medical literature. One case series evaluating RFVTR reported on 18 patients with obstructive sleep apnea who had a sub-optimal response to a prior UPPP and had a documented tongue base obstruction. The baseline mean AHI was 39.6/hour. After the procedure, that AHI dropped to a mean level of 17.8. However, at a mean follow-up of 28 months in 16 of these patients, this had increased to 28.7. The hypopnea index had risen to 22.9 from pre- and post-treatment levels of 17.4 and 13.6 respectively, and the mean oxygen saturation nadir had fallen to 85.8% from a post-treatment value of 88.3%. In a separate multi-institutional study of 56 patients with obstructive sleep apnea treated with radiofrequency tongue base reduction, the mean pre-operative apnea/hypopnea index of 40.5 decreased only to 32.8 after treatment. Another case series reported on a group of 20 patients with a pretreatment AHI of 28/hour. In 13 of the 20 patients, the AHI dropped by 50%, which was considered a success. In the remaining patients, the index did not significantly improve; in one patient the index dramatically deteriorated. A recently published randomized trial involving 90 patients with mild to moderate obstructive sleep apnea used radiofrequency ablation of both tongue and palate in 30 with comparisons to groups receiving CPAP or sham radiofrequency treatment. Very short-term results only were reported, and there was no significant reduction in either AHI or nocturnal oxygen desaturation in the radiofrequency treated group. Studies with longer-term outcomes would be useful in evaluating the benefits of this procedure.

A prospective non-randomized trial using a cautery-assisted palatal stiffening operation (CAPSO) procedure for the treatment of excessive snoring in 206 consecutive patients reported a "success" rate of 92% initially, falling to 77% at one year. Of note is the fact that the patients with features suggestive of obstructive sleep apnea or with evidence of obstructive sleep apnea on sleep studies were excluded from the trial. A small study involving 25 patients with obstructive sleep apnea reported a 40% success rate in terms of a reduction in Apnea-Hypopnea index of 50% or more and to less than 10. The mean Apnea-Hypopnea index improved from 25.1 to 16.6. There was no significant improvement in nocturnal oxygen desaturation, and the follow-up period was only 3 months.

LAUP has primarily been researched as a treatment of snoring, without associated clinically significant obstructive sleep apnea. Thus, outcomes studies have focused on the elimination of snoring and not on pre- and post-procedure apnea/hypopnea indices. In one study of 22 patients with mild obstructive sleep apnea, pre- and post-polysomnograms were performed, along with assessments of daytime sleepiness. Patients with an apnea/hypopnea index of greater than 15/hour were specifically excluded from the trial. After a mean number of three treatments, the AHI was not significantly different from baseline. The degree of excessive daytime sleepiness, as measured by the Epworth Sleepiness scale, improved from 8.5 to 5.2. It should be noted that a value of 10 or below is considered normal. Practice Parameters for the use of LAUP updated in 2000 by the Standards of Practice Committee of the American Academy of Sleep Medicine do not recommend LAUP for the treatment of sleep- related breathing disorders.

Electrosleep therapy has been proposed as a method of inducing sleep in individuals with sleep disorders. At this time, there is very little medical evidence indicating that this is an effective method of treatment. The level of evidence available to suitably evaluate the efficacy or safety of electrosleep therapy is currently insufficient to allow conclusions.

Two newer treatment methods proposed for OSA are the Repose^® bone-anchored suspension system (Influence Corp; San Francisco, CA), and injection snoreplasty. Currently, the available literature on these procedures is limited to a half dozen case series studies. Neither of these treatments has been evaluated long-term, and the numbers of patients studied is very small. At this time, there is insufficient evidence to make any recommendation about the appropriate clinical use of either the Repose^® system or injection snoreplasty.

To date, the literature has been limited regarding the safety and efficacy of the Pillar^TM palatal implant system for treating OSA. Friedman (2008) reported a single institution, randomized controlled trial, involving 62 patients with mild to moderate OSA who were selected based on "Friedman tongue position," soft palate size, and BMI < 32. Only 29 patients actually received the palatal implant and follow-up analysis. 26 patients underwent a "sham" procedure and analysis as the placebo group. Follow-up was performed at three months, and success was defined as an AHI reduction of at least 50% and a post procedure AHI < 20. On this basis, 13/29 patients receiving the implants were a success (44.8%), compared to 0 in the placebo group. However, four (4) of the 13 "successes" already had a pre-procedure AHI of < 20, as did nine (9) of the 26 in the placebo group. In the implant group, the mean AHI fell from 23.8 to 15.9, this latter number still representing moderate OSA, (as defined by the American Academy of Sleep Medicine [AASM]). In addition, the mean Epworth Sleepiness Scale score fell from 12.7 to 10.2, the latter continuing to represent excessive daytime sleepiness (> 10). No individual patient data were reported, and it is unknown if OSA was completely relieved (AHI< 5) in any patients. Mean minimum O2 saturation rose from 88.3% to 89.7% (significance unclear) with quality of life (QOL) responses following treatment that were measured using an SF 36 rather than a more specific sleep-related QOL measurement tool. Acknowledged limitations of the study by the authors were the short follow-up (which precludes conclusions regarding the durability of the implant procedure) and the potential challenge in generalizing results arising from a limited study population of non-obese, mild to moderate OSA patients with specific oral physical characteristics where half of the patients evaluated did not qualify for the study (Friedman, 2008).

Walker (2007) reported follow-up at approximately 15 months for 22 patients out of an original 53 patients undergoing the Pillar palatal implant procedure for mild to moderate OSA at four sites in the U.S. Of these 22 patients, 13 had experienced a mean decrease in AHI from 19.5 to 13 at 90 days post implant; (an AHI of 13 represents mild OSA by AASM definition). Ten of these 13 (76.9%) maintained a mean AHI of 12.8 (persistent mild OSA) at approximately 15 months post-procedure. There was some concern about the finding that 9/22 patients, who had not improved 90 days post-procedure, experienced an increase in mean AHI from 19.9 pre-procedure to 28.4 at 90 days post-procedure and 26.2 at extended follow-up. Whether this early and sustained deterioration was related to the failed implant procedure or to the natural history of OSA is unclear. As with the Friedman study, no individual patient data were reported, and no information was provided as to whether any patients had their OSA totally relieved by the implant procedure. Limitations of this case series study include the small sample size, lack of placebo control group, and the significant number of the original 53 patients who were lost to follow-up which affected the generalizability of the results (Walker, 2007).

In summary, available studies, to date, do not provide convincing evidence of the long-term efficacy of palatal implants for patients with OSA. Larger randomized controlled trials with longer follow-up and more complete patient data post-procedure are required to establish the procedure's efficacy for OSA.

Another new technique that has been proposed as a surgical alternative for the treatment of OSA is transpalatal advancement pharyngoplasty (TAP). This surgical procedure alters the retro-palatal airway by advancing the palate forward without requiring excision of the soft palate. This procedure pulls the palate forward and superiorly. Conceptually, similarities exist to maxillary advancement without the associated alterations in dentition. The TAP procedure has been purported for use alone or in combination with other soft tissue surgeries for patients with narrowing in the retro-palatal airway, especially narrowing proximal to the point of palatal excision using traditional UPPP techniques. A transpalatal approach and advancement has also been proposed for patients with obstructions in the nasopharynx, such as enlarged adenoids, that cannot be accessed through traditional techniques. However, to date, there is very little published outcomes data for patients with OSA. One retrospective review described 30 patients who underwent a TAP procedure; twenty of these study subjects also had various tongue-base procedures performed at the same time as TAP. Only ten had TAP alone. The results of post-operative AHI in these 30 patients were better than a comparable group of 44 patients undergoing UPPP, 26 of whom had UPPP as the sole procedure. Also, for the patients in each group who did not have additional tongue base surgery, the AHI improved significantly more in the TAP treated patients (n=10) than the UPPP treated patients (n=26). (Woodson, 2005) Larger studies are needed to establish the safety/efficacy of the TAP procedure, together with prospective comparisons with established palate-based surgical techniques.

Description of Sleep Apnea

According to the American Academy of Family Physicians, obstructive sleep apnea (OSA) syndrome affects over 18 million people in the United States. However, many of these people have never had a proper diagnosis. Sleep apnea is characterized by an interruption of breathing during sleep, due to extra or loose tissue in the upper airway that collapses into the air passage with the effort of inhalation. This is often linked to obesity and decreased muscle tone due to aging. When the airway becomes blocked, a drop in blood oxygen content can occur which is detected by the brain, causing the patient to wake just enough to tighten the airway muscles and allow breathing to then resume. This may occur several hundred times in one night. Obstructive sleep apnea can cause many symptoms, such as depression, irritability, sexual dysfunction, learning and memory difficulties, and falling asleep while at work or driving.

Description of OSA Treatments

Treatments for OSA include various non-surgical methods, including oral appliances, continuous positive airway pressure (CPAP) therapy, and a variety of surgical treatments. Oral appliances are custom fitted devices placed into the mouth to reposition the patient's jaw or tongue during sleep to reduce the occurrence of obstructive sleep apnea. Several types of over-the-counter devices are available; custom fabricated or prefabricated appliances that have been custom fitted can usually assure the most effective intervention for this type of device. Fitting for an oral appliance is a painless and easy procedure where a medical professional makes a mold or takes measurements of the inside of the mouth. The device is then custom made and worn by the patient nightly. These devices are very similar to orthodontic retainers or sports mouth guards. Patients may find them uncomfortable but easy to use, and usually the discomfort is temporary. Side effects of these devices may include excess salivation, headache, and skin irritation.

Uvulopalatopharyngoplasty (UPPP) is a surgical procedure involving the removal of excessive tissue in the upper airway, including tonsils and uvula, to widen the area to increase airflow. Complications of this surgery may include swelling, pain, infection, bleeding, reflux of secretions into the nose, and a nasal quality to the voice. This procedure typically requires an inpatient stay and is used for the treatment of severe OSA.

Hyoid myotomy is a surgical procedure that involves movement of the hyoid bone in the neck. The hyoid bone is a c-shaped bone located above the Adam's apple, to which the base of the tongue and other soft tissues of the throat are anchored. Hyoid myotomy involves the surgical detachment of these soft tissues from the hyoid bone and then reattaching them in a manner that places increased tension on the tissues. This increased tension is intended to decrease soft tissue collapse of the upper airway that is characteristic of sleep apnea.

Genioglossus advancement is a surgical procedure that involves alteration of the anchor point for the genioglossus muscle of the tongue. This point is located on the inside of the lower jaw. During this procedure, the area of bone surrounding the anchor point is separated from the rest of the jaw bone and pulled outward, drawing the tongue away from the back of the throat. This serves to prevent the base of the tongue from blocking the upper airway during sleep.

In circumstances where oral appliances, CPAP and UPPP or other surgical procedures have failed, or the patient has jaw or facial abnormalities that impair breathing function, jaw realignment surgery may be indicated. Jaw realignment surgery is an extensive procedure, in which the upper and lower jaws are advanced several millimeters to improve airflow through the back of the throat. Several surgeries may be required. Patients undergoing jaw realignment surgery typically also undergo orthodontic therapy to correct changes in tooth alignment, associated with the surgery. Change in facial appearance is common in this type of surgery. Other side effects of the procedure include swelling, pain, dental mal-alignment requiring correction, and bleeding.

Many other surgical methods have been proposed for the treatment of OSA, which use various methods of removing or ablating excess tissue from the upper airway, predominantly the soft palate and in some cases the base of the tongue. Of these proposed methods, radiofrequency ablation techniques use high frequency radio waves to destroy tissue of the soft palate, nasal turbinates and/or base of the tongue to decrease excess tissues in the back of the throat. Radiofrequency ablative techniques include Radiofrequency Volumetric Tissue Reduction (RFVTR), Coblation^® and Somnoplasty^®. Patients undergoing these procedures frequently require multiple treatments for adequate results. Another category of treatment that aims to remove excess tissue from the upper airway uses heat from either a laser or an electrocautery device to destroy tissue of the soft palate. The two approaches currently available that use this method are laser-assisted uvulopalatoplasty (LAUP) and cautery-assisted palatal stiffening operation (CAPSO). Injection snoreplasty is a newer technique that proposes the injection of chemicals into the soft palate that supposedly causes them to shrink and harden, decreasing excess tissue to block the airway.

Another new method recently proposed for the treatment of OSA is the Repose^® system. This system involves the insertion of a bone screw into the inside of the lower jaw. A cable is then threaded through the base of the tongue and anchored to the bone screw. This system is used to prevent the base of the tongue from falling into the airway, which has been indicated as a cause of some OSA symptoms.

Injection snoreplasty has been proposed as a treatment of both snoring and OSA. This procedure, frequently done in 1 to 3 separate treatments, involves injection of a chemical (Sotradecol) into the soft palate and uvula. Sotradecol is known as a sclerotherapy agent, and causes scarring via an inflammatory reaction in the tissues to which it is exposed. The scarring caused by Sotradecol causes the flabby loose tissue in the back of the throat to shrink and tighten, which is proposed to open the upper airway and decrease the symptoms of snoring and OSA.

The Pillar^TM Palatal Implant System (Restore Medical, Inc. St. Paul, MN) consists of three narrow threads of braided polyester slightly less than an inch in length that are inserted under the skin of the soft palate, using a delivery tool. One is placed in the midline and one each in right and left lateral locations. The procedure can be performed in the physician's office under local anesthesia, and over the next few weeks, scar tissue grows around the threads further stiffening the palate. The implants are designed to be permanent structures but can be removed if necessary for reasons of infection or instability. Post operative pain is claimed to be mild and short lived with rapid resumption of normal activities and diet (unlike LAUP and RFVTR). The PillarTM system received market clearance from the U.S. Food & Drug Administration in 2003.

Proposed Benefits

The goal of all sleep disorder diagnostic procedures is to correctly identify a specific sleep disorder(s), in order to render proper treatment(s). Such treatment may alleviate sleep disorder symptoms and/or causes and allow a patient to achieve healthy sleep patterns.

Sleep apnea treatment is intended to alleviate or eliminate the occurrence of sleep apnea. This in turn should allow the patient to achieve healthy sleep patterns and mitigate or eliminate the symptoms of OSA.

Potential Risks

The level of risk associated with the various methods of OSA treatment varies dependent upon the level of invasiveness. The use of oral appliances poses little risk to patients, but proper fitting should be done to assure optimal efficacy. The risks associated with CPAP and its derivatives are not life threatening, but include disturbed sleep until the patient is acclimated to the device.

Various surgical treatments for OSA all include the standard risks associated with all surgical treatments, including infection, bleeding, pain and discomfort. Not all procedures are guaranteed to be 100% successful, and results may vary by patient. All of these surgeries result in permanent reconfiguration of the anatomical position of a patient's upper airway, which may have unintended consequences. Patients undergoing jaw realignment should be especially aware that this surgery will most likely affect their appearance.

The following codes for treatments and procedures applicable to this document 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.

Oral Appliances
When services may be Medically Necessary when criteria are met: 

When services are Not Medically Necessary:
For the procedure codes listed above, when criteria are not met; for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

Surgical Treatments

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above, when criteria are not met; for the following diagnosis, or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

When services are also Not Medically Necessary:

When services are Investigational and Not Medically Necessary:
For the procedures listed above, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary. 

When services are Investigational and Not Medically Necessary:

When services are also Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. Black JE, Guilleminault C, Colrain JM, et al.  Upper airway resistance syndrome. Am J Respir Crit Care Med. 2000; 162:406-411.
2. Bloch KE, Iseli A, Zhang JN, et al. A randomized, controlled crossover trial of two oral appliances for sleep apnea treatment. Am J Respir Crit Care Med. 2000; 162(1):246-251.
3. Blumen MB, Dahan S, Fleury B, et al. Radiofrequency ablation for the treatment of mild to moderate obstructive sleep apnea. Laryngoscope. 2002; 112(11):2086-2092.
4. Boudewyns A, Van De Heyning P.  Temperature controlled radiofrequency tissue volume reduction of the soft palate (somnoplasty) in the treatment of habitual snoring: results of a European multicenter trial. Acta Otolaryngol. 2000; 120:981-985.
5. Brietzke SE, Mair EA. Injection snoreplasty: extended follow-up and new objective data. Otolaryngol Head Neck Surg. 2003; 128(5):605-615.
6. Cho LD, Kushida Ca, Guilleminault C, et al.  Upper airway resistance syndrome: sleep stage thresholds for esophageal-pressure-related arousals.  Sleep Research. 1997; 26:344. 
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14. Ferguson KA, Heighway K, Ruby RR. A randomized trial of laser-assisted uvulopalatoplasty in the treatment of mild obstructive sleep apnea. Am J Respir Crit Care Med. 2003; 167(1):15-19.
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17. Friedman M, et al. Does severity of obstructive sleep apnea/hypopnea syndrome predict uvulopalatopharyngoplasty outcome?  Laryngoscope. 2005; 115:2109-2113.
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20. Husain AM. Evaluation and comparison of tranquility and AutoSet T autotitrating CP machines. Journal of Clinical Neurophysiology. 2003, 20(4):291-295.
21. Janson C, et al. Long-term follow-up of patients with obstructive sleep apnea treated with uvulopalatopharyngoplasty. Archives of Otolaryngology - Head and Neck Surgery. 1997; 123(3):257-262.
22. Krahn AD, Yee R, Erickson MK, et al. Physiologic pacing in patients with obstructive sleep apnea: a prospective randomized crossover trial.  J Am Coll Cardiol. 2006; 47(2):379-383.
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26. Li KK. Surgical management of obstructive sleep apnea. Clinics in Chest Medicine. 2003: 24(2):365-370.
27. Lowe AA, Sjoholm TT, Ryan CF, et al.  Treatment, airway and compliance effects of a titratable oral appliance.  Sleep. 2000; 23(3):51-57.
28. Mair, EA, Day RH.  Cautery-Assisted Palatal Stiffening Operation.  Otolaryngology - Head and Neck Surgery. 2000; 122(4):547-556.
29. Marklund M, Stenlund H, Franklin KA. Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. Chest. 2004; 125(4):1270-1278.
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31. Mehta A, Qian J, Petocz P, et al. A randomized controlled study of a mandibular advancement splint for obstructive sleep apnea. Am J Respir Crit Care Med. 2001; 163(6):1457-1461.
32. Miller FR, Watson D, Malis D. Role of the tongue base suspension suture with The Repose System bone screw in the multilevel surgical management of obstructive sleep apnea. Otolaryngol Head Neck Surg. 2002; 126(4):392-398.
33. Millman RP, Rosenberg CL, Kramer NR.  Oral appliances in the treatment of snoring and sleep apnea. Clinics Chest Med. 1998; 19(1)69-75.
34. Millman RP, et al. Simple predictors of uvulopalatopharyngoplasty outcome in the treatment of obstructive sleep apnea. Chest. 2000; 118(4):1025-1030.
35. Nelson LM. Combined temperature-controlled radiofrequency tongue reduction and UPPP in apnea surgery. Ear Nose Throat J. 2001; 80(9):640-644.
36. Nordgård S, Hein G, Stene BK, et al. One-year results: Palatal implants for the treatment of obstructive sleep apnea. Otolaryngol Head Neck Surg. 2007; 136(5):818-822.
37. Pang KP, Terris DJ. Modified cautery-assisted palatal stiffening operation: new method for treating snoring and mild obstructive sleep apnea. Otolaryngol Head Neck Surg. 2007; 136(5):823-826.
38. Peppard PE, et al. Prospective study of the association between sleep disordered breathing and hypertension. N Engl J Med. 2000; 342(19):1378-1384.
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44. Sher AE. Upper airway surgery for obstructive sleep apnea. Sleep Med. Rev. 2002; 6(3):195-212.
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50. Terris DJ, Coker JF, Thomas A J, Chavoya M. Preliminary findings from a prospective, randomized trial of two palatal operations for sleep-disordered breathing. Otolaryngol Head Neck Surg. 2002; 127(4):315-323.
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53. Tucker Woodson B, et al. A randomized trial of temperature-controlled radiofrequency, continuous positive airway pressure and placebo for obstructive sleep apnea syndrome. Otolaryngology-Head and Neck Surgery. 2003; 28(6):848-861.
54. Walker RP, Levine HL, Hopp ML, Greene D. Extended follow-up of palatal implants for OSA treatment. Otolaryngol Head Neck Surg. 2007; 137(5):822-827. 
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Government Agency, Medical Society, and Other Authoritative Publications:

1. 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; 19:152-155.
2. Blue Cross and Blue Shield Association. Surgical procedure for the treatment of obstructive apnea syndrome. TEC Assessment, 1996; 10(31).
3. Blue Cross and Blue Shield Association. Radio-frequency volumetric tissue reduction for sleep-related breathing disorders. TEC Assessment, 2000; 13(15).
4. Bridgman S, Dunn K, Ducharme F.  Surgery for obstructive apnea. Cochrane Database Syst. Rev. 2004; (3).
5. Canadian Agency for Drugs and Technologies in Health (CADTH). Obstructive sleep apnea: A palatable treatment option? Issues in Emerging health Technologies, Issue 97. Ottawa, ON: CADTH; January 2007. Available at: http://www.cadth.ca/media/pdf/E0008_obstructive-sleep-apnea_cetap_e.pdf.  Accessed on August 12, 2009.
6. Centers for Medicare and Medicaid Services. National Coverage Determination for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA). NCD #240.4. Effective March 13, 2008.  Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=240.4&ncd_version=3&basket=ncd%3A240%2E4%3A3%3AContinuous+Positive+Airway+Pressure+%28CPAP%29+Therapy+For+Obstructive+Sleep+Apnea+%28OSA%29.  Accessed on August 12, 2009.
7. Centers for Medicare and Medicaid Services. National Coverage Determination for Laser Procedures. NCD #140.5.  Effective May 1, 1997. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on August 12, 2009.
8. Epstein LJ, Kristo D, Strollo PJ, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009; 5(3):263-276.  Available at:  http://www.aasmnet.org/Resources/ClinicalGuidelines/OSA_Adults.pdf.  Accessed on August 12, 2009.
9. Hayes Inc. Hayes Medical Technology Directory. Sleep Apnea Treatment, Surgical. Lansdale, PA: Hayes, Inc; September 13, 2005.  Search updated October 4, 2008.
10. Hayes Inc. Hayes Medical Technology Directory. Sleep Apnea Treatment, Devices. Lansdale, PA: Hayes, Inc; September 16, 1999.  Search updated March 14, 2005.
11. Hayes Inc. Hayes Medical Technology Directory. Radiofrequency Tissue Volume Reduction (RFTVR) for the Treatment of Upper Airway Obstruction. Lansdale, PA: Hayes, Inc; March 30, 2007. Search updated April 4, 2009.
12. Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of obstructive sleep apnea.  Health Care Guideline.  Bloomington, MN: Institute for Clinical systems Improvement (ICSI); released July 2008.  Available at: http://www.icsi.org/guidelines_and_more/gl_os_prot/respiratory/sleep_apnea/sleep_apnea__diagnosis_and_treatment_of_obstructive_3.html.  Accessed on August 11, 2009.
13. Kushida CA, Morgenthaler TI, Littner MR, et al. Practice parameters for the treatment of snoring and Obstructive Sleep Apnea with oral appliances: an update for 2005. Sleep. 2006; 29(2):240-243.
14. Littner M, et al. Practice Parameters for the Use of Laser-Assisted Uvulopalatoplasty: An Update for 2000. Sleep. 2001; 24(5):603-619.
15. Lim J, Lasserson TJ, Fleetham J, et al. Oral appliances for obstructive sleep apnea.  Cochrane Database Syst Rev. 2006; (1):CD004435.
16. Morgenthaler TI, Kapen S, Lee-Chiong T, et al. Standards of Practice Committee, American Academy of Sleep Medicine (AASM). Practice parameters for the medical therapy of obstructive sleep apnea. Sleep. 2006; 29(8):1031-1035.
17. Mundy L, Sullivan T, Merlin T, et al. Horizon Scanning Unit, Adelaide Health Technology Assessment, University of Adelaide. The Pillar procedure: For the treatment of obstructive sleep apnoea and snoring. Horizon Scanning Report. Canberra, ACT: HealthPACT Secretariat, Department of Health and Ageing, Australian Government; September 2006. Available at: http://www.health.adelaide.edu.au/publichealth/research/horizon_scanning.html.  Accessed on August 12, 2009.
18. National Institute for Clinical Excellence (NICE). Radiofrequency ablation of the soft palate for snoring. Interventional Procedure Guidance No.124 . London, UK: NICE; May 2005. Available at: http://www.nice.org.uk/nicemedia/pdf/ip/IPG124guidance.pdf.  Accessed on August 12, 2009.
19. National Institute for Health and Clinical Excellence (NICE). Soft palate implants for obstructive sleep apnoea syndrome. Interventional Procedure Guidance 241. London, UK: NICE; November 2007. Available at: http://www.nice.org.uk/nicemedia/pdf/IPG241Guidance.pdf.  Accessed on August 12, 2009.
20. National Institute for Health and Clinical Excellence (NICE). Soft palate implants for simple snoring. Interventional Procedure Guidance 240. London, UK: NICE; November 2007. Available at: http://www.nice.org.uk/nicemedia/pdf/IPG240QRG.pdf.  Accessed on August 12, 2009.
21. Thorpy M, Chesson A, Derderian S, et al. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances. An American Sleep Disorders Report. Sleep. 1995; 18:511-513.
22. Thorpy M, Chesson A, Derderian S, et al. Practice parameters for the treatment of obstructive sleep apnea in adults: the efficacy of surgical modifications of the upper airway. Standards of Practice Committee of the American Sleep Disorders Association. Available at: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=8774&nbr=4852#s23.  Accessed on August 12, 2009.
23. U.S. Food and Drug Administration (FDA) Center for Devices and Radiologic Health (CDRH) 510(k) Premarket Notification Database. Pillar^™ Palatal Implant System. Summary of Safety and Effectiveness. No. K040417. Rockville, MD:FDA. July 28, 2004. Available at:   http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040417.pdf.  Accessed on August 12, 2009.

1. Journal of the American Medical Association.  Patient Page. Breathing Problems During Sleep. Available at: http://www.medem.com/medlb/article_detaillb.cfm?article_ID=ZZZWT155MNC&sub_cat=593 Accessed on August 12, 2009.

Apnea/Hypopnea Index (AHI)
Cautery-Assisted Palatal Stiffening Operation (CAPSO)
C-flex
Coblation^®
DPAP
Electrosleep Therapy
Genioglossal (Genioglossus) Advancement
Laser-Assisted Uvulopalatopharyngoplasty (LAUP)
Obstructive Sleep Apnea
Pillar Implant
Radiofrequency Ablation of Palatal Tissues and the Base of Tongue
RF Thermal Ablation
SNAP^® Testing
Snore Guard
Somnoplasty System™
Topographic EEG Mapping
Uvulopalatopharyngoplasty

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.