CMS Surgical Treatment of Obstructive Sleep Apnea (OSA) Form

Summary Of Evidence

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Analysis of Evidence

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Sleep-Disordered Breathing, often referred to as Obstructive Sleep Apnea (OSA), is characterized by frequent episodes of hypopnea or apnea during sleep. Multiple detrimental physiologic changes may result from these hypopneic and apneic episodes. Non-surgical and surgical approaches to obstructive apnea and hypopnea have been developed.

Continuous Positive Airway Pressure (CPAP) breathing is the treatment of choice for OSA. Some patients do not tolerate CPAP or are not benefited from it. The level of obstruction in OSA (retropalatal, retrolingual, and retropalatal and retrolingual) is variable.

Uvulopalatopharyngoplasty (UPPP) is an accepted means of surgical treatment for this disorder but is curative in less than 50% of patients. Scientific evidence suggests that UPPP is useful in retropalatal and combination retropalatal and retrolingual obstruction.

Mandibular Maxillary Osteotomy and Advancement is a procedure developed for those patients with retrolingual obstruction, or those patients with retropalatal and retrolingual obstruction who have not responded to CPAP and uvulopalatopharyngoplasty. Medical data on the efficacy of this treatment has been reported from only a small number of centers, but the information appears to show good results for those patients who meet certain criteria. It is unknown whether the technique will result in similar results outside specialized centers.

Tracheostomy remains the surgical approach with the greatest effectiveness since it bypasses all areas of obstruction in the nasal, palatal, lingual, and pharyngeal areas. However, tracheostomy is associated with significant morbidity, and is usually reserved for patients who have failed other medical or surgical methods of treatment, or who are unsuitable for other methods of treatment for various reasons.

Various other anatomic abnormalities (such as, but not limited to, enlarged tonsils or tongue) sometimes cause OSA also. Surgical approaches to these abnormalities will vary according to the anatomic defect and the procedure/procedures needed to correct the defined problem.

Genioglossal advancement, with or without resuspension of the hyoid bone, may be performed with uvulopalatopharyngoplasty, but this procedure is not always successful, and there is little definitive information on its benefit.

1. Uvulopalatopharyngoplasty (UPPP) is covered for those patients who have all of the following:
   1. Obstructive sleep apnea diagnosed (prior to any proposed surgery) in a certified sleep disorders laboratory (certification body recognized by the American Academy of Sleep Medicine);
   2. A Respiratory Disturbance Index of 15 or higher;
   3. Failed to respond to Continuous Positive Airway Pressure therapy or cannot tolerate CPAP or other appropriate non-invasive treatment;
   4. Documented counseling by a physician, with recognized training in sleep disorders, about the potential benefits and risks of the surgery; and
   5. Evidence of retropalatal or combination retropalatal/retrolingual obstruction as the cause of the obstructive sleep apnea.
2. Mandibular Maxillary Osteotomy and Advancement and /or genioglossus advancement with or without hyoid suspension is covered for those patients who have all of the following:
   1. Obstructive sleep apnea diagnosed (prior to any proposed surgery) in a certified sleep disorders laboratory (certification body recognized by the American Academy of Sleep Medicine);
   2. A Respiratory Disturbance Index of 15 or higher;
   3. Failed to respond to Continuous Positive Airway Pressure therapy or cannot tolerate CPAP or other appropriate non-invasive treatment;
   4. Documented counseling by a physician, with recognized training in sleep disorders, about the potential benefits and risks of the surgery; and
   5. Evidence of retrolingual obstruction as the cause of the obstructive sleep apnea, or previous failure of UPPP to correct the obstructive sleep apnea.
      Regarding the Mandibular Maxillary Osteotomy and Advancement operation:
      1. Separate repositioning of teeth would not be necessary except under unusual circumstances; but if necessary, the dental work would be covered.
      2. Application of an interdental fixation device is occasionally necessary and is a covered service (see Documentation Requirements).
3. Tracheostomy is covered for obstructive sleep apnea that is in the judgment of the attending physician, unresponsive to other means of treatment or in cases where other means of treatment would be ineffective or not indicated.
4. When obstructive sleep apnea is caused by discrete anatomic abnormalities of the upper airway (such as, but not limited to, enlarged tonsils or an enlarged tongue), surgery to correct these abnormalities is covered if medically necessary based on adequate documentation in the medical records supporting the significant contribution of these abnormalities to OSA. Submucous radiofrequency reduction of hypertrophied turbinates is covered as an appropriate treatment for nasal obstruction due to turbinate hypertrophy that significantly contributes to OSA or significantly compromises CPAP therapy.
5. The following procedures are not covered at this time.
   1. Laser-assisted uvulopalatoplasty (LAUP) is not covered at this time since it is not considered effective for OSA.
   2. Somnoplasty™ is a trade name for palate reduction with the Somnoplasty™ System of Somnus Medical Systems. This is not a term recognized by this Contractor as a covered procedure under Medicare Part B. 
   3. The Pillar Procedure™ is a trade name for palatal implants. Palatal implants have not  been shown effective for the treatment of obstructive sleep apnea and are not covered.
   4. Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session. will be denied as investigational and experimental.