LCD L34526

Coverage Guidance

CMS Pub. 100-02 Medicare Benefit Policy Manual Chapter 15 §70- Sleep Disorder Clinics;

Chapter 16 §140 Dental Services Exclusion

CMS Pub. 100-03 Medicare National Coverage Determinations Manual Chapter 1, Part 4 §240.4 Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA)

Social Security Act 1862 (a)(1)(A) Medically Reasonable & Necessary.

Social Security Act 1862 (a)(1)(D) Investigational or Experimental.

CMS Transmittal No, 857, effective date October 3, 2018 Change Request 10901 Local Coverage Determinations (LCDs) Implementation date January 8, 2019.

Indications and Limitations of Coverage

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.

• Uvulopalatopharyngoplasty (UPPP) is covered for those patients who have all of the following:

• 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);

• A Respiratory Disturbance Index of 15 or higher;

• Failed to respond to Continuous Positive Airway Pressure therapy or cannot tolerate CPAP or other appropriate non-invasive treatment;

• Documented counseling by a physician, with recognized training in sleep disorders, about the potential benefits and risks of the surgery; and

• Evidence of retropalatal or combination retropalatal/retrolingual obstruction as the cause of the obstructive sleep apnea.

• 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:

• 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);

• A Respiratory Disturbance Index of 15 or higher;

• Failed to respond to Continuous Positive Airway Pressure therapy or cannot tolerate CPAP or other appropriate non-invasive treatment;

• Documented counseling by a physician, with recognized training in sleep disorders, about the potential benefits and risks of the surgery; and

• 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:

• Separate repositioning of teeth would not be necessary except under unusual circumstances; but if necessary, the dental work would be covered.

• Application of an interdental fixation device is occasionally necessary and is a covered service (see Documentation Requirements).

• 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.

• 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.

• The following procedures are not covered at this time.

• Laser-assisted uvulopalatoplasty (LAUP) is not covered at this time since it is not considered effective for OSA.

• 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.

• 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.

• Submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session. will be denied as investigational and experimental.

Summary of Evidence

NA

Analysis of Evidence

NA

Associated Information

Documentation Requirements

Physicians' Services and diagnostic tests/x-rays must be submitted with a diagnosis code to support medical necessity and must be coded to the greatest level of specificity and the highest level of digit completeness. The precise diagnosis code that most fully explains the narrative diagnosis contained in the medical record or test interpretation/report is expected. The diagnosis code based on the results of the test should be the primary diagnosis. If the test results are normal or inconclusive the diagnosis code representing the sign, symptom, illness or injury prompting the ordering of the test/x-ray should be reported as the primary diagnosis. In the absence of signs, symptoms, illness or injury, a screening diagnosis code should be reported, and payment will be denied.

The patient's medical records must be legible, contain the relevant history, and physical findings conforming to the criteria listed under the "Coverage Indications, Limitations, and/or Medical Necessity" section, and must be made available to the contractor upon request.

Documentation of the counseling of the risks and benefits of the procedure must be included in the patient's medical records and must be made available to the contractor on request.

Documentation of adequate trial of CPAP or other modes of continuous positive airway pressure therapy for obstructive sleep apnea under the care of a physician specifically trained in sleep disordered breathing must also be included in the patient's medical record and must be made available to the contractor on request. Absence of this information could result in denial.

After adequate healing of the surgical site, a follow-up evaluation by a physician with recognized training in sleep disorders is recommended and should be documented accordingly.

Bibliography

Aurora, R. N., Casey, K.R., & et al. (2010). Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. SLEEP, 33(10): 1408-13.

Caples, S.M., Rowley, J.A., & et al. Surgical modifications of the upper airway for obstructive sleep apnea in adults: A systematic review and meta-analysis. SLEEP, 33(10):1396-1407.

Larrosa, F., Hernandez, L., & et al. (July, 2004). Laser-assisted uvulopalatoplasty for snoring: does it meet the expectations? European Respiratory Journal, (1):66-70.

Littner, M., Kushida, C., & et.al. Practice parameters for the use of laser-assisted uvulopalatoplasty: An update for 2000. SLEEP, 24(5).