This policy addresses both non-surgical and surgical treatments for obstructive sleep apnea in adults. This includes continuous positive airway pressure (CPAP) and related variants, 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-MED-01Polysomnography Studies in Adults and Children;
• Clinical UM Guideline CG-DME-27Non-invasive Positive Pressure Respiratory Assist Devices (BiPAP®).

Medically Necessary:

Non-Surgical Treatments

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 policy, 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 treatments in adults are considered medically necessary:

Continuous Positive Airway Pressure and Related Devices:

Continuous Positive Airway Pressure (CPAP) is considered medically necessary for the treatment of:

• obstructive sleep apnea meeting the above criteria; or
• upper airway resistance syndrome (UARS) as defined by AHI (or RDI) less than 5/hr but with more than 10 EEG arousals/hr associated with increased respiratory efforts (with or without concomitant observed snoring) and increased negative esophageal pressure (more negative than –10cms H2O).

Bilevel Positive Airway Pressure (BiPAP) is considered medically necessary when used by patients diagnosed with obstructive sleep apnea or upper airway resistance syndrome (UARS) when CPAP has failed.

Note:  Please refer to CG-DME-27 Non-invasive Positive Pressure Respiratory Assist Devices (BiPAP®) for the medical necessity criteria for BiPAP.

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 H20) complaining of pressure discomfort.

Auto-CPAP (APAP) is considered medically necessary as a second or third line alternative therapy for obstructive sleep apnea when documentation of the following is available:

1. The level of fixed CPAP required is at least 10cms H2O as evidenced by an in- laboratory, technician-attended CPAP titration during polysomnography; and
2. The patient is intolerant of high fixed CPAP pressures (>10cms. H2O) despite appropriate patient education and interventions to improve patient comfort and compliance. These interventions should include:
   • The use of a topical nasal corticosteroid spray or anticholinergic spray if nasal complaints are significant; and
   • Changes made by a nurse or technician, in consultation with the attending physician, to the CPAP circuit or mask, using different nose masks, face masks, nasal pillows or head harnesses as appropriate to achieve maximum patient comfort.

Oral Appliances:

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

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) with or without hyoid myotomy and suspension, and/or genioglossal advancement for the treatment of OSA is considered medically necessary for patients who have failed treatment with CPAP and UPPP, with or without genioglossus tongue advancement and/or hyoid myotomy with suspension.

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.

Not Medically Necessary:

Unattended auto-CPAP (APAP) is considered not medically necessary as an alternative to technician-titrated CPAP in patients with OSA, or for the treatment of patients with the following conditions:

• Central apnea;
• Congestive heart failure;
• Lung disease (e.g., chronic obstructive pulmonary disease);
• Nocturnal O2 desaturation due to conditions other than obstructive sleep apnea
• Absence of snoring (either natural or secondary to palatal surgery). [In these cases, APAP devices relying on vibration or sound in the device’s algorithm should not be used.]

Individual consideration for the use of Auto-CPAP to determine the therapeutic level of CPAP may be applied in situations when a diagnosis of obstructive sleep apnea has been made by polysomnography [or in special circumstances by Type 3 monitor - see “home/portable monitoring” section in MED.00002 Diagnosis of Sleep Disorders] and the patient is unable to undergo CPAP titration in a sleep laboratory setting within a reasonable time period.

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 (CAPSO) or Palatal Implants.

Investigational/Not Medically Necessary:

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

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

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

All other sleep disorder treatments are considered investigational/not medically necessary including, but not limited to, the following:

1. Cautery-assisted Palatal Stiffening Operation (CAPSO);
2. Electrosleep therapy;
3. Flexible positive airway pressure (PAP) (e.g., C-Flex);
4. Laser-Assisted Uvulopalatoplasty (LAUP);
5. Radiofrequency Volumetric Tissue Reduction (RFVTR) of the soft palate and/or the base of the tongue including Somnoplasty® and Coblation;®
6. The Repose® System.

Currently, peer-reviewed medical literature supports the use of CPAP for the treatment of obstructive sleep apnea and Upper Airway Resistance Syndrome (UARS). Standard CPAP, and the variants BiPAP and Auto-CPAP, have been found in randomized controlled trials to be highly effective in decreasing, and in some cases eliminating, obstructive sleep apnea events in patients with mild to moderate sleep apnea.  Additionally, there is clinical trial evidence that CPAP and its variants may provide significant benefit to patients suffering from restrictive lung disease and who demonstrate nocturnal oxygen desaturation.

There is evidence in the medical literature to support the use of oral appliances for the treatment of OSA. The American Sleep Disorders Association has stated that there is adequate information to support the use of oral appliances in the following cases: patients with mild OSA who are not appropriate candidates for treatment with weight loss and behavioral therapy; during the period of weight loss or adapting to sleep position changes; patients with moderate to severe OSA who are intolerant to CPAP or refuse CPAP treatment; and patients who refuse or are not candidates for tonsillectomy and adenoidectomy, uvulopalatopharyngoplasty, or jaw realignment.

Auto-titrating continuous positive airway pressure (auto-CPAP or APAP) utilizes a device that continually adjusts the level of pressure as needed to maintain airway patency. It has been investigated both as a means to establish the required level of therapeutic “fixed” CPAP for long-term use (as an alternative to sleep laboratory, technician titrated CPAP), and as a long-term therapeutic alternative to fixed CPAP.

Auto-titration typically takes place unattended in the home over 1-2 weeks and has been promoted as obviating the need for a second polysomnography study for CPAP titration, should a split night study not be feasible. However studies of the reliability of auto titration (particularly unattended) have yielded mixed results with problems related to mask leaks or need for other attendant interventions, and variable monitoring parameters and technologies used by different devices. The 2002 Practice Parameters for the use of these devices published by the Standards of Practice Committee of the American Academy of Sleep Medicine state that the “Use of unattended APAP to either initially determine pressures for fixed CPAP or for self adjusting CPAP in CPAP naïve patients is not currently established.”  As a therapeutic alternative to fixed CPAP, there is a theoretical advantage based on the use of lower mean airway pressures and improved patient compliance. However, most studies have not demonstrated improved compliance using auto-CPAP, nor have functional outcomes (e.g., daytime sleepiness) been superior to those seen with fixed CPAP.

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 genioglosus 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 genioglosus 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 deformation related to OSA.   The literature on this procedure indicates that success varies with the experience of the surgeon and 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 02 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 CAPSO 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 O2 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 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 discussing the use of the Pillar^TM system has addressed snoring only, with data available from the manufacturer’s literature (Restore Medical, Inc.).  In this body of evidence, patients with obstructive sleep apnea have been excluded.  In the absence of adequate data addressing and supporting the use of the Pillar^TM   system for patients with OSA, we consider this device investigational for this purpose.

C-flex is a variation on CPAP that adjusts airway pressure during exhalation, keeping it low initially but increasing it towards end exhalation up to therapeutic CPAP levels, thereby preventing airway collapse, (which tends to occur towards end exhalation). Supposedly, this increases CPAP compliance based on improved patient comfort. Aloia et al '05 study is a small, non-randomized study demonstrating increased CPAP use (hrs per night) at 3 months using the C-flex system, compared to standard CPAP. However, clinical outcomes were not significantly different. Additionally, there were flaws, in terms of patient unblinding, (i.e., some knew they were using C-flex) and lack of use of C-flex technology to titrate that treatment group. Further randomized studies are needed to compare health outcomes using C-flex with both standard and other forms of PAP delivery for OSA.

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, but only a custom fitted device can 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.

Continuous Positive Airway Pressure (CPAP) is the most common and effective treatment for sleep apnea.  During sleep, the patient wears a mask over the nose attached to an air compressor that forces air through the nasal passages, opening the back of the throat. In OSA, tissues in the upper airway, including the tongue, soft palate and nasal passages sag and block the airway. The pressurized air in CPAP forces the tissues in the upper airway out of the way, allowing normal breathing to occur during sleep.  Variations of the CPAP device, including auto-CPAP, BiPAP and DPAP, adjust the airflow to the needs of the patient.  Some side effects that may occur include discomfort, nasal irritation and drying, facial skin irritation, abdominal bloating, mask leaks, sore eyes, and headaches.  CPAP prevents airway closure while in use, but apnea episodes return when CPAP is stopped or if it is used improperly.

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 Volumentric 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, a newer technique 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.) 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 RFA).  The Pillar^TM  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 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.

CPAP and Related Devices
When services are Medically Necessary:

HCPCS

ICD-9 Diagnosis

BiPAP and APAP Devices
When services may be Medically Necessary when criteria are met:

HCPCS

ICD-9 Diagnosis

When services are Not Medically Necessary:

For the procedure codes listed above when criteria are not met; or when the code describes a procedure indicated in the Policy section as not medically necessary.

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

HCPCS

ICD-9 Diagnosis

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 Policy section as not medically necessary.

Surgical Treatments
When services may be Medically Necessary when criteria are met:

CPT

HCPCS

ICD-9 Procedure

ICD-9 Diagnosis

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 Policy section as not medically necessary.

ICD-9 Diagnosis

When services are also Not Medically Necessary:

CPT

HCPCS

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

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

When services are Investigational/Not Medically Necessary:

CPT

HCPCS

ICD-9 Diagnosis

When services are also Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

Peer Reviewed Publications:

1. Aloia MS, Stanchina M, et al. Treatment adherence and outcomes in flexible vs standard continuous positive airway pressure therapy. Chest. 2005 Jun;127(6):2085-93.
2. Ayes NT. Auto-titrating Versus Standard Continuous Positive Airway Pressure for the Treatment of Obstructive Sleep Apnea: Results of a Meta-analysis. Sleep 27 (2) 2004. 
3. Black JE, Guilleminault C, Colrain JM, et al.  Upper airway resistance syndrome. Am J Respir Crit Care Med. 2000;162:406-11.
4. 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. 
5. Blumen MB, Dahan S, Fleury B, et al. Radiofrequency ablation for the treatment of mild to moderate obstructive sleep apnea. Laryngoscope. 2002; 112(11):2086-92. 
6. 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. 
7. Brietzke SE, Mair EA. Injection snoreplasty: extended follow-up and new objective data. Otolaryngol Head Neck Surg. 2003; 128(5):605-15. 
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16. Flicker JH, Wiest GH, Lehnert G, et al.  Evaluation of an auto-CPAP device for treatment of obstructive sleep apnea.  Thorax. 1998; 53:643-648. 
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18. Friedman M et al. Does severity of Obstructive Sleep Apnea/Hypopnea Syndrome Predict Uvulopalatopharyngoplasty  Outcome ?  Laryngoscope 2005; 115: 2109-2113.
19. Husain AM Evaluation and Comparison of Tranquility and AutoSet T autotitrating CP_CP machines. Journal of Clinical Neurophysiology. 2003, 20(4):291-5. 
20. 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):257-62.
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23. 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):379-83.
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25. Li KK. Surgical management of obstructive sleep apnea. Clinics in Chest Medicine. 2003: 24(2): 365-70. 
26. Loube DI, et al. Indications for Positive Airway Pressure Treatment of Adult Obstructive Sleep Apnea Patients: A consensus statement. Chest Vol.115 No3 March 1999. 
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, E.A., Day,R.H.  Cautery-Assisted Palatal Stiffening Operation.  Otolaryngology - Head and Neck Surgery, April 2000; 122(4): 547-56. 
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):1270-8. 
30. Maurer JT, Verse T, Stuck BA, Hormann K, Hein G. Palatal implants for primary snoring: short-term results of a new minimally invasive surgical technique. Otolaryngol Head Neck Surg. 2005;132(1):125-31.
31. 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):392-8. 
32. Millman RP, Rosenberg CL, Kramer NR.  Oral appliances in the treatment of snoring and sleep apnea. Clinics Chest Med. 1998; 19(1)69-75.
33. Millman RP, et al. Simple predictors of uvulopalatopharyngoplasty outcome in the treatment of obstructive sleep apnea. Chest 2000;118(4):1025-30.
34. Nelson LM. Combined temperature-controlled radiofrequency tongue reduction and UPPP in apnea surgery. Ear Nose Throat J. 2001; 80(9):640-4. 
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40. Senn S. Randomized Short-term Trial of Two AutoCPAP Devices versus Fixed Continuous Positive Airway Pressure for the Treatment of Sleep Apnea. Am J Respir Crit Care Med 168. pp1506-11, 2003. 
41. Sher AE, Flexon PB, Hillman D, et al.  Temperature controlled radiofrequency tissue volume reduction in the human soft palate.  Otolaryngology Head and Neck Surg. 2001; 125(4):312-318.
42. Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep 1996;19(2):156-77. 
43. Sher AE. Upper airway surgery for obstructive sleep apnea. Sleep Med. Rev. 2002 June; 6(3): 195-212.
44. Silverberg D, Iaina A.  Treating obstructive sleep apnea improves essential hypertension and quality of life. Am Fam Phys. 2002; 65(2):229-236.
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47. Stuck BA, Maurer JT, Verse T, Hormann K. Tongue base reduction with temperature-controlled radiofrequency volumetric tissue reduction for treatment of obstructive sleep apnea syndrome. Acta Otolaryngol. 2002; 122(5):531-6. 
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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; 19:152-55.
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. 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 April 4, 2005. Available at: http://www.cms.hhs.gov. Accessed on: October 17, 2006.
6. 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. Accessed on: October 17, 2006.
7. Giles TL, Lasserson TJ, Smith BJ, et al. Continuous positive airway pressure for obstructive sleep apnea in adults. Cochrane Database Syst Rev. 2006; (1):CD001106.
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12. Littner M, et al. Practice Parameters for the Use of Laser-Assisted Uvulopalatoplasty: An Update for 2000. Sleep. 2001; 24(5):603-619.
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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: October 17, 2006.
2. National Center on Sleep Disorders Research. Available at: http://www.nhlbi.nih.gov/about/ncsdr/index.htm Accessed on:: October 17, 2006.
3. National Library of Medicine.  Medline Plus Health Information. Sleep Apnea. Available at: http://www.nlm.nih.gov/medlineplus/sleepapnea.html Accessed on:: October 17, 2006.

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.