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Medical Policy: 07.01.43
Original Effective Date: November 2008
Reviewed: May 2011
Revised: July 2011
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction due to the collapse and obstruction of the upper airway during sleep. In patients with OSA, the normal pharyngeal narrowing may be accentuated by anatomic factors, such as a short, fat “bull” neck, elongated palate and uvula, and large tonsillar pillars with redundant lateral pharyngeal wall mucosa. In addition, OSA is associated with obesity. OSA may also be associated with a variety of craniofacial abnormalities, including micrognathia, retrognathia, or maxillary hypoplasia. Obstruction anywhere along the upper airway can result in apnea. Therefore, OSA is associated with a heterogeneous group of anatomic variants producing obstruction.
The hallmark symptom of OSA is excessive daytime sleepiness, and the typical clinical sign of OSA is snoring, which can abruptly cease and be followed by gasping associated with a brief arousal from sleep. The snoring resumes when the patient falls back to sleep, and the cycle of snoring/apnea/arousal may be repeated as frequently as every minute throughout the night. Sleep fragmentation associated with the repeated arousal during sleep can lead to impairment of daytime activity. For example, adult patients with OSA-associated daytime somnolence are thought to be at higher risk for accidents involving motorized vehicles, i.e., cars, trucks, or heavy equipment. OSA in children may result in neurocognitive impairment and behavioral problems. In addition, OSA affects the cardiovascular and pulmonary systems. For example, apnea leads to periods of hypoxia, alveolar hypoventilation, hypercapnia, and acidosis. This in turn can cause systemic hypertension, cardiac arrhythmias, and cor pulmonale. Systemic hypertension is common in patients with OSA. Severe OSA is also associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile accidents related to overwhelming sleepiness.
The final diagnosis of OSA rests on a combination of clinical evaluation and objective criteria to identify those levels of obstruction that are considered to be clinically significant. The gold standard diagnostic test for sleep disorders is considered a polysomnogram, which includes sleep staging to assess arousals from sleep, and determination of the frequency of apneas and hypopneas from channels measuring oxygen desaturation, respiratory airflow, and respiratory effort. An obstructive apnea is defined as at least a 10-second cessation of respiration associated with ongoing ventilatory effort. Obstructive hypopnea is an equal to or greater than 30% reduction of air exchange with an associated fall in oxygen saturation of at least 3-4%. Respiratory event-related arousals (RERAs) are scored if there is a sequence of breaths lasting at least 10 seconds characterized by increasing respiratory effort or flattening of the nasal pressure waveform leading to an arousal from sleep when the sequence of breaths does not meet criteria for an apnea or hypopnea. The apnea/hypopnea index (AHI) is defined as the total number of apneas and hypopneas per hour of sleep. The respiratory disturbance index (RDI) may be defined as the number of apneas, hypopneas, and RERAs per hour of sleep. When sleep onset and offset are unknown (e.g., in home sleep studies), the RDI may be calculated based on the number of apneas and hypopneas per hour of recording time. OSA is considered to be clinically significant when an adult patient has an AHI greater than 5 and symptoms of excessive daytime sleepiness or unexplained hypertension. An AHI greater than or equal to 15 is typically considered moderate OSA, while an AHI greater than 50 is considered severe OSA. Due to faster respiratory rates in children, pediatric scoring criteria define an apnea as 2 or more missed breaths, regardless of its duration in seconds. Hypopneas are scored by a 50% or greater drop in nasal pressure and either an equal to or greater than 3% decrease in oxygen saturation or an associated arousal. In pediatric patients, an AHI greater than 1.5 is considered abnormal, and an AHI of 15 or more is considered severe.
A condition related to OSA has been termed upper airway resistance syndrome (UARS). UARS is characterized by a partial collapse of the airway resulting in increased resistance to airflow. The increased respiratory effort is associated with multiple sleep fragmentations, as measured by very short alpha electrocardiogram (EEG) arousals (RERAs). UARS can occur in the absence of snoring and in patients who are not overweight. The resistance to airflow is typically subtle and does not result in apneic or hypopneic events. However, increasingly negative intrathoracic pressure during inspiration can be measured using an esophageal manometer. RERAs can also be detected absent manometry during polysomnography. It has been proposed that UARS is a distinct syndrome from OSA that may be considered a disease of arousal. In the absence of intrathoracic pressure monitoring, a positive response to continuous positive airway pressure (CPAP) has also been used to support the diagnosis.
Treatment
Nonsurgical treatment for OSA or UARS includes CPAP or orthodontic repositioning devices, which are addressed in policy No. 07.01.21. Traditional surgeries for OSA or UARS include uvulopalatopharyngoplasty (UPPP) and a variety of maxillofacial surgeries such as mandibular-maxillary advancement (MMA). UPPP involves surgical resection of the mucosa and submucosa of the soft palate, tonsillar fossa, and the lateral aspect of the uvula. The amount of tissue removed is individualized for each patient as determined by the potential space and width of the tonsillar pillar mucosa between the 2 palatal arches. The UPPP enlarges the oropharynx but cannot correct obstructions in the hypopharynx. Thus, patients who fail UPPP may be candidates for additional procedures, depending on the site of obstruction. Additional procedures include hyoid suspensions, maxillary and mandibular osteotomies, or modification of the tongue. Fiberoptic endoscopy and/or cephalometric measurements have been used as methods to identify hypopharyngeal obstruction in these patients. The first-line treatment in children is usually adenotonsillectomy. Minimally invasive surgical approaches being evaluated for OSA in adults include the following:
Laser-assisted Uvulopalatoplasty (LAUP)
LAUP is an outpatient alternative that has been proposed as a treatment of snoring with or without associated OSA. In this procedure, superficial palatal tissues are sequentially reshaped using a carbon dioxide laser. The extent of the surgery is typically different than standard UPPP, since only part of the uvula and associated soft-palate tissues are reshaped. The procedure, as initially described, does not remove or alter tonsils or lateral pharyngeal wall tissues. The patient undergoes from 3 to 7 sessions at 3- to 4-week intervals. One purported advantage of LAUP is that the amount of tissue ablated can be titrated such that the treatment can be discontinued once snoring is eliminated. LAUP cannot be considered an equivalent procedure to the standard UPPP, with the laser simply representing a surgical tool that the physician may opt to use. LAUP is considered a unique procedure, which raises its own issues of safety and, in particular, effectiveness.
Radiofrequency Ablation (RFA) of Palatal Tissues and the Tongue
RFA of the soft palate is similar in concept to LAUP, although a different energy source is used. Radiofrequency is used to produce thermal lesions within the tissues rather than using a laser to ablate the tissue surface, which may be painful. For this reason, RFA appears to be growing in popularity as an alternative to LAUP. In some situations, radiofrequency of the soft palate and base of tongue are performed together as a multilevel procedure.
Tongue Base Suspension
In this procedure, the base of the tongue is suspended with a suture that is passed through the tongue and then fixated with a screw to the inner side of the mandible, below the tooth roots. The aim of the suspension is to make it less likely for the base of the tongue to prolapse during sleep.
Palatal Stiffening
Palatal stiffening procedures include insertion of palatal implants, injection of a sclerosing agent (snoreplasty), or a cautery-assisted palatal stiffening operation (CAPSO). The CAPSO procedure uses cautery to induce a midline palatal scar designed to stiffen the soft palate to eliminate excessive snoring. The palatal implant device is a cylindrical-shaped segment of braided polyester filaments that is permanently implanted submucosally in the soft palate.
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Prior Approval:
Prior approval is recommended for uvulopalatopharyngoplasty (UPPP), hyoid suspension, surgical modification of the tongue and/or maxillofacial surgery, including mandibular-maxillary advancement (MMA), and adenotonsillectomy for OSA in pediatric patients. Submit a prior approval now.
Prior approval is not recommended for minimally-invasive surgical procedures*
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Policy:
Uvulopalatopharyngoplasty (UPPP) may be considered medically necessary for the treatment of clinically significant obstructive sleep apnea syndrome (OSA) in appropriately selected adult patients (18 years of age and older) who have not responded to or do not tolerate nasal continuous positive airway pressure (CPAP). Clinically significant OSA is defined as those patients who have:
- Apnea/hypopnea index (AHI) or respiratory disturbance index (RDI) greater than or equal to 15 events per hour, or
- AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.
Hyoid suspension, surgical modification of the tongue, and/or maxillofacial surgery, including mandibular-maxillary advancement (MMA), may be considered medically necessary in appropriately selected adult patients (18 years of age and older) with clinically significant OSA and objective documentation of hypopharyngeal obstruction who have not responded to or do not tolerate CPAP. Clinically significant OSA is defined as those patients who have:
- AHI or RDI greater than or equal to 15 events per hour, or
- AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.
Adenotonsillectomy may be considered medically necessary in pediatric patients with clinically significant OSA and hypertrophic tonsils. Clinically significant OSA is defined as those pediatric patients who have:
- AHI or RDI of at least 5 per hour, or
- AHI or RDI of at least 1.5 per hour in a patient with excessive daytime sleepiness, behavioral problems, or hyperactivity.
*The following minimally-invasive surgical procedures are considered investigational for the sole or adjunctive treatment of obstructive sleep apnea (OSA) or upper airway resistance syndrome (UARS):
- Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency reduction of the palatal tissues
- Laser-assisted palatoplasty (LAUP) or radiofrequency volumetric tissue reduction of the palatal tissues
- Palatal stiffening procedures including, but not limited to, cautery-assisted palatal stiffening operation, injection of a sclerosing agent, and the implantation of palatal implants
- Tongue base suspension
- All other minimally-invasive surgical procedures not described above.
All interventions, including LAUP, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, are considered not medically necessary for the treatment of snoring in the absence of documented OSA; snoring alone is not considered a medical condition.
Reminder – prior approval is not recommended for minimally invasive procedures
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 42145 Palatopharyngoplasty (eg, uvulopalatopharyngoplasty, uvulopharyngoplasty)
- 21199 Osteotomy, mandible, segmental; with genioglossus advancement
- 41512 Tongue base suspension, permanent suture technique
- 41530 Submucosal radiofrequency tissue volume reduction of tongue base, one or more sites, per session
- 42299 Unlisted procedure, palate, uvula
- S2080 Laser-assisted uvulopalatoplasty (LAUP)
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Selected References:
- The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
- A review of the medical literature and recommendations from the Medical Policy Advisory Council (MPAC), which assists Wellmark’s medical directors in the development of medical policies. MPAC is comprised of practicing physicians from Iowa and South Dakota.
- Woodson BT. Surgical approaches to obstructive sleep apnea. Current Opinion in Pulmonary Medicine 1998;4:344-350.
- Hailey D, Tran K, et al. A review of guidelines for referral of patients to sleep laboratories [Technology report no 55]. Ottawa: Canadian Coordinating Office for Health Technology Assessment; 2005.
- Fukuse T, Satoda N, Hijiya K, Fujinaga T. Importance of a comprehensive geriatric assessment in prediction of complications following thoracic surgery in elderly patients. Chest. 2005 Mar;127(3):886-91.
- Goode RL. Success and Failure in Treatment of Sleep Apnea Patients. Otolaryngol Clin N Am. 2007 Aug;40(4):891-901.
- Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of obstructive sleep apnea in adults. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2008 Jun. 55p.
- Epstein LJ, Kristo D, Strollo PJ Jr. Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Acaemy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.
- Aurora R, Casey K, Kristo D, et al. Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep. 2010 May;33(10): 1408-1413.
- ECRI Institute. Genioglossus Advancement with hyoid myotomy for obstructive sleep apnea and snoring. Plymouth Meeting (PA): ECRI Institure: 2010 Oct. 25. 6p. [ECRI hotline response]. Also available: http://www.ecri.org.
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Policy History:
Date Reason Action
May 2011 Annual review Policy renewed
July 2011 Interim review Policy revised
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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