Medical policy: Surgical Treatment of Sleep Apnea and Snoring

Número de política: MP 1.128

Fecha de entrada en vigor: 8/1/2025

Política

Obstructive sleep apnea

Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty, uvulopharyngoplasty, uvulopalatopharyngoplasty flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty) may be considered medically necessary for the treatment of clinically significant obstructive sleep apnea (OSA) syndrome in appropriately selected adults who have failed an adequate trial of continuous positive airway pressure (CPAP) or failed an adequate trial of an oral appliance.

Clinically significant OSA is defined as those individuals who have:

• Apnea/hypopnea index (AHI) or respiratory disturbance index (RDI) of 15 or more events per hour; or
• AHI or RDI of at least 5 events per hour with 1 or more signs or symptoms associated with OSA (e.g., excessive daytime sleepiness, hypertension, cardiovascular heart disease, or 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 adults with clinically significant OSA and objective documentation of hypopharyngeal obstruction who have failed an adequate trial of CPAP or failed an adequate trial of an oral appliance.

Clinically significant OSA is defined as those individuals who have:

• AHI or RDI of 15 or more events per hour; or
• AHI or RDI of at least 5 events per hour with 1 or more signs or symptoms associated with OSA (e.g., excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke).

Adenotonsillectomy may be considered medically necessary in pediatric individuals with clinically significant OSA and hypertrophic tonsils.

Clinically significant OSA is defined as those pediatric individuals who have:

• AHI or RDI of at least 5 per hour; or
• AHI or RDI of at least 1.5 per hour in an individual with excessive daytime sleepiness, behavioral problems, or hyperactivity.

Hypoglossal nerve stimulation may be considered medically necessary in adults with OSA under the following conditions:

• Age ≥18 years; and
• AHI ≥15 and ≤100 with ≤25% central apneas; and
• CPAP failure (residual AHI ≥15) or failure to use CPAP ≥4 hr per night for ≥5 nights per week) or inability to tolerate CPAP; and
• Body mass index ≤35 kg/m²; and
• Absence of complete concentric collapse at the soft palate level (see Policy Guidelines).

Hypoglossal nerve stimulation may be considered medically necessary in adolescents or young adults with Down syndrome and OSA under the following conditions:

• Age 13 to 18 years; and
• AHI ≥10 and ≤50 with ≤25% central apneas after prior adenotonsillectomy; and
• Have either tracheotomy or be ineffectively treated with CPAP due to noncompliance, discomfort, undesirable side effects, persistent symptoms despite compliance use, or refusal to use the device; and
• Body mass index ≤95th percentile for age; and
• Absence of complete concentric collapse at the soft palate level (see Policy Guidelines).

Surgical treatment of OSA that does not meet the criteria above would be considered investigational as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure.

The following minimally invasive surgical procedures are considered investigational for the sole or adjunctive treatment of OSA or upper airway resistance syndrome as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure:

• Laser-assisted palatoplasty or radiofrequency volumetric tissue reduction of the palatal tissues;
• Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency 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.

Implantable hypoglossal nerve stimulators are considered investigational for all indications other than those listed above as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure.

All interventions, including laser-assisted palatoplasty, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, are considered investigational for the treatment of snoring in the absence of documented OSA as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure; snoring alone is not considered a medical condition.

Central sleep apnea

The use of phrenic nerve stimulation for central sleep apnea is considered investigational in all situations as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure.

Directrices de la política

Septoplasty for obstructive sleep disorders is addressed in MP 1.004.

Continuous positive airway pressure is the preferred first-line treatment for most patients. A smaller number of patients may use oral appliances as a first-line treatment (see evidence review 2.045).

The apnea/hypopnea index is the total number of events (apnea or hypopnea) per hour of recorded sleep. The respiratory disturbance index is the total number of events (apnea or hypopnea) per hour of recording time. An obstructive apnea is defined as at least a 10-second cessation of respiration associated with ongoing ventilatory effort. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow compared with baseline and with at least a 4% oxygen desaturation.

The hypoglossal nerve (cranial nerve XII) innervates the genioglossus muscle. Stimulation of the nerve causes anterior movement and stiffening of the tongue and dilation of the pharynx. Hypoglossal nerve stimulation reduces airway collapsibility and alleviates obstruction at both the level of the soft palate and tongue base.

Drug-induced sleep endoscopy (DISE) replicates sleep with an infusion of propofol. DISE will suggest either a flat, anterior-posterior collapse or complete circumferential oropharyngeal collapse. Concentric collapse decreases the success of hypoglossal nerve stimulation and is an exclusion criterion from the Food and Drug Administration.

Cross-references:

• MP 1.004 Cosmetic and Reconstructive Surgery
• MP 1.101 Orthognathic Surgery
• MP 2.045 Diagnosis of Obstructive Sleep Apnea
• MP 2.062 Temporomandibular Disorder
• MP 2.372 Occipital Nerve Stimulation

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/Antecedentes

Obstructive sleep apnea

Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction due to collapse and obstruction of the upper airway during sleep. 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 impair daytime activity. For example, adults with OSA-associated daytime somnolence are thought to be at high risk for accidents involving motorized vehicles (i.e., cars, trucks, 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 associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile accidents related to overwhelming sleepiness.

There are racial and ethnic health disparities seen for OSA, impacting the prevalence of disease and accessibility to treatment options, particularly affecting children. Black children are 4 to 6 times more likely to have OSA than White children. Among young adults 26 years of age or younger, African American individuals are 88% more likely to have OSA compared to White individuals. Another study found that African American individuals 65 years of age and older were 2.1 times more likely to have severe OSA than White individuals of the same age group. These health disparities may affect accessibility to treatment for OSA and impact health outcomes. One analysis of insurance claims data, including over 500,000 patients with a diagnosis of OSA, found that increased age above the 18 to 29-year range (p<0.001) and Black race (p=0.020) were independently associated with a decreased likelihood of receiving surgery for sleep apnea. Lee et al. (2022) found that Black men had a continuous mortality increase specifically related to OSA over the study period (1999 to 2019; annual percent change 2.7%; 95% confidence interval, 1.2 to 4.2) compared to any other racial group.

Regulatory status

The regulatory status of minimally invasive surgical interventions is shown in Table 1.

Table 1. Minimally invasive surgical interventions for obstructive sleep apnea

AHI: Apnea/Hypopnea Index; CPAP: continuous positive airway pressure; IDE: investigational device exemption; LAUP: Laser-assisted uvulopalatoplasty; OSA: obstructive sleep apnea.

The expanded indication for hypoglossal nerve stimulation in patients ages 18 to 21 was based on patients with Down syndrome and is contingent on a post-approval study of the Inspire^® upper airway stimulation (UAS) in this age group. The post-approval study will be a multicenter, single-arm, prospective registry with 60 pediatric patients ages 18 to 21. Visits will be scheduled at pre-implant, post-implant, 6 months, and yearly thereafter through 5 years.

Central sleep apnea

Central sleep apnea (CSA) is characterized by repetitive cessation or decrease in both airflow and ventilatory effort during sleep. Central sleep apnea may be idiopathic or secondary (associated with a medical condition such as congestive heart failure, drugs, or high-altitude breathing). Apneas associated with Cheyne-Stokes respiration are common among patients with heart failure (HF) or who have had strokes, and account for about half of the population with CSA. Central sleep apnea is less common than obstructive sleep apnea. Based on analyses of a large community-based cohort of participants 40 years of age and older in the Sleep Heart Health Study, the estimated prevalence of CSA and obstructive sleep apnea are 0.9% and 47.6%, respectively. Risk factors for CSA include age (>65 years), male gender, history of HF, history of stroke, other medical conditions (acromegaly, renal failure, atrial fibrillation, low cervical tetraplegia, and primary mitochondrial diseases), and opioid use. Individuals with CSA have difficulty maintaining sleep and therefore experience excessive daytime sleepiness, poor concentration, and morning headaches, and are at higher risk for accidents and injuries.

Tratamiento

The goal of treatment is to normalize sleep-related breathing patterns. Because most cases of CSA are secondary to an underlying condition, central nervous system pathology, or medication side effects, treatment of the underlying condition or removal of the medication may improve CSA. Treatment recommendations differ depending on the classification of CSA as either hyperventilation-related (most common, including primary CSA and those relating to HF or high-altitude breathing) or hypoventilation-related (less common, relating to central nervous system diseases or use of nervous system suppressing drugs such as opioids).

For patients with hyperventilation-related CSA, continuous positive airway pressure (CPAP) is considered first-line therapy. Due to CPAP discomfort, patient compliance may become an issue. Supplemental oxygen during sleep may be considered for patients experiencing hypoxia during sleep or who cannot tolerate CPAP. Patients with CSA due to HF with an ejection fraction >45%, and who are not responding with CPAP and oxygen therapy, may consider bilevel positive airway pressure or adaptive servo-ventilation (ASV) as second-line therapy. Bilevel positive airway pressure devices have 2 pressure settings, 1 for inhalation and 1 for exhalation. Adaptive servo-ventilation uses both inspiratory and expiratory pressure and titrates the pressure to maintain adequate air movement. However, a clinical trial reported increased cardiovascular mortality with ASV in patients with CSA due to HF and with an ejection fraction <45%, and therefore, ASV is not recommended for this group.

For patients with hypoventilation-related CSA, first-line therapy is bilevel positive airway pressure.

Pharmacologic therapy with a respiratory stimulant may be recommended to patients with hyper- or hypoventilation CSA who do not benefit from positive airway pressure devices, though close monitoring is necessary due to the potential for adverse effects such as rapid heart rate, high blood pressure, and panic attacks.

Phrenic nerve stimulation

Several phrenic nerve stimulation systems are available for patients who are ventilator dependent. These systems stimulate the phrenic nerve in the chest, which sends signals to the diaphragm to restore a normal breathing pattern. Currently, the only phrenic nerve stimulation device approved by the U.S. Food and Drug Administration (FDA) for CSA is the remedē^® system (Zoll Medical). A cardiologist implants the battery-powered device under the skin in the right or left pectoral region using local anesthesia. The device has 2 leads, 1 to stimulate a phrenic nerve (either the left pericardiophrenic or right brachiocephalic vein) and 1 to sense breathing. The device runs off an algorithm that activates automatically at night when the patient is in a sleeping position and suspends therapy when the patient sits up. Patient-specific changes in programming can be conducted externally by a programmer.

Regulatory status

In October 2017, the remedē^® system (Respicardia, Inc. [now Zoll Medical]; Minnetonka, MN) was approved by the FDA through the premarket approval application process (PMA #P160039). The approved indication is for the treatment of moderate to severe CSA in adults. Follow-up will continue for 5 years in the post-approval study. FDA product code: PSR.

Fundamento

Summary of evidence

Obstructive sleep apnea

For individuals who have OSA who receive laser-assisted uvulopalatoplasty, the evidence includes a single randomized controlled trial (RCT). Los resultados pertinentes son los síntomas, los resultados funcionales, la calidad de vida y la morbilidad relacionada con el tratamiento. The trial indicates reductions in snoring, but limited efficacy on the apnea/hypopnea index (AHI) or symptoms in patients with mild-to-moderate OSA. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive radiofrequency volumetric reduction of palatal tissues and base of tongue, the evidence includes 2 sham-controlled randomized trials. Los resultados pertinentes son los síntomas, los resultados funcionales, la calidad de vida y la morbilidad relacionada con el tratamiento. Single-stage radiofrequency to palatal tissues did not improve outcomes compared with sham. Multiple sessions of radiofrequency to the palate and base of tongue did not significantly (statistically or clinically) improve AHI, and the improvement in functional outcomes was not clinically significant. The prospective cohort study included 56 patients with mild-to-moderate OSA who received 3 sessions of office-based multilevel RFA. Results demonstrated improvement in AHI and oxygen desaturation index (ODI) at the 6-month follow-up. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive palatal stiffening procedures, the evidence includes two sham-controlled randomized trials. Los resultados pertinentes son los síntomas, los resultados funcionales, la calidad de vida y la morbilidad relacionada con el tratamiento. The 2 RCTs differed in their inclusion criteria, with the study that excluded patients with Friedman tongue position of IV and palate of 3.5 cm or longer reporting greater improvement in AHI (45% success) and snoring (change of -4.7 on a 10-point visual analog scale) than the second trial. Additional studies are needed to corroborate these results. The more successful trial, if successful, defined the appropriate selection criteria. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive tongue base suspension, the evidence includes a feasibility RCT with 17 patients. Los resultados pertinentes son los síntomas, los resultados funcionales, la calidad de vida y la morbilidad relacionada con el tratamiento. The single RCT compared tongue base suspension to uvulopalatopharyngoplasty (UPPP) and showed success rates of 50% to 57% for both procedures. Additional RCTs with a larger number of subjects are needed to determine whether tongue suspension alone or added to UPPP improves the net health outcome. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have OSA who receive hypoglossal nerve stimulation (HNS), the evidence includes systematic reviews, 3 RCTs, nonrandomized prospective studies, nonrandomized studies with historical controls, and prospective single-arm studies. Los resultados pertinentes son los síntomas, los resultados funcionales, la calidad de vida y la morbilidad relacionada con el tratamiento. A double-blind, multicenter RCT of 89 adults with moderate-to-severe OSA who did not tolerate CPAP showed significant short-term improvements in AHI, Epworth Sleepiness Scale (ESS), and quality of life measures with HNS compared to sham stimulation. The study was limited by short duration of follow-up and lack of diversity amongst included participants. Another RCT including 138 patients with moderate-to-severe OSA who did not tolerate CPAP compared outcomes for patients who received HNS therapy at 1 or 4 months after implant for the treatment and control groups, respectively. Results demonstrated significant short-term improvement in AHI and ODI when comparing HNS to no HNS at month 4. However, after 11 months of active therapy, the difference between the treatment and control groups was not statistically significant for AHI, but remained significant for ODI in favor of the treatment group. This trial was also limited by a lack of diverse individuals and a lack of a control group for long-term outcomes. Hypoglossal nerve stimulation has shown success rates of about two-thirds of a subset of patients who met selection criteria that included AHI, body mass index (≤32 or ≤35 kg/m²), and favorable pattern of palatal collapse across nonrandomized trials. These results were maintained up to 5 years in the pivotal single-arm study. The single prospective comparative study of patients who received HNS versus patients who were denied insurance coverage for the procedure has a high potential for performance bias. For children and adolescents with OSA and Down syndrome who are unable to tolerate CPAP, the evidence includes a systematic review and a prospective study of 42 individuals. The systematic review investigated HNS in adolescents with Down syndrome and OSA, and demonstrated significant improvement in AHI and OSA-18 survey scores after HNS. A study of 42 individuals with Down syndrome and OSA found a success rate of 73.2% with 4 device exclusions corrected with replacement surgery. Limitations of the current evidence base preclude determination of who is most likely to benefit from this invasive procedure. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Información adicional

2018 input

Clinical input was sought to help determine whether the use of hypoglossal nerve stimulation in individuals with obstructive sleep apnea would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 2 respondents, including 1 specialty society-level response and physicians with academic medical center affiliation.

For individuals who have OSA who receive HNS, clinical input supports that this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice in subgroups of appropriately selected patients. One subgroup includes adult patients with a favorable pattern of non-concentric palatal collapse. The alternative treatment for this anatomic endpoint is maxillomandibular advancement (MMA), which is associated with greater morbidity and lower patient acceptance than HNS. The improvement in AHI with HNS, as shown in the STAR trial, is similar to the improvement in AHI following MMA. Another subgroup includes appropriately selected adolescents with OSA and Down syndrome who have difficulty using CPAP. The following patient selection criteria are based on information from clinical study populations and clinical expert opinion:

• Age ≥22 years in adults or adolescents with Down syndrome age 10 to 21; and
• Diagnosed moderate to severe OSA (with less than 25% central apneas); and
• CPAP failure or inability to tolerate CPAP; and
• Body mass index ≤32 kg/m² in adults; and
• Favorable pattern of palatal collapse.

Central sleep apnea

For individuals with CSA who receive phrenic nerve stimulation, the evidence includes a systematic review, 1 randomized controlled trial (RCT), and observational studies. Relevant outcomes are change in disease status, functional outcomes, and quality of life. The RCT compared the use of phrenic nerve stimulation to no treatment among patients with CSA of various etiologies. All patients received implantation of the phrenic nerve stimulation system, with activation of the system after 1 month in the intervention group and activation after 6 months in the control group. Activation is delayed 1 month after implantation to allow for lead healing. At 6 months follow-up, the patients demonstrated significant improvement in sleep metrics and quality of life measures. At 12 months follow-up, patients in the activated device arm showed sustained significant improvements from baseline in sleep metrics and quality of life. A subgroup analysis of patients with heart failure combined 6- and 12-month data from patients in the intervention group and 12- and 18-month data from the control group. Results from this subgroup analysis showed significant improvements in sleep metrics and quality of life at 12 months compared with baseline. Results from observational studies supported the results of the RCT. An invasive procedure would typically be considered only if non-surgical treatments had failed, but there is limited data in which phrenic nerve stimulation was evaluated in patients who had failed the current standard of care, positive airway pressure, or respiratory stimulant medication. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

Apnea/hypopnea index (AHI) is the average number of apneas or hypopneas per hour of sleep.

Apnea in adults is defined as a drop in airflow by ≥90% of the pre-event baseline for at least ten (10) seconds. Due to faster respiratory rates in children, pediatric scoring criteria define apnea as ≥2 missed breaths, regardless of its duration in seconds.

Hypopnea in adults is scored when the peak airflow drops by at least 30% of the pre-event baseline for at least 10 seconds in association with either at least 3% or 4% decrease in arterial oxygen saturation (depending on the scoring criteria). Hypopneas in children are scored by a ≥50% drop in nasal pressure and either a ≥3% decrease in oxygen saturation or associated arousal.

Intra-oral appliance is a device placed in the mouth to correct or alleviate malocclusion.

Palatopharyngoplasty refers to a surgical procedure that opens the airway by removing or reshaping tissue in the throat.

Respiratory disturbance index (RDI) is the number of apneas, hypopneas, or respiratory event-related arousals per hour of sleep time. RDI is often used synonymously with the AHI.

Respiratory event index (REI) is the number of events per hour of monitoring time. It is used as an alternative to AHI or RDI in home sleep studies when actual sleep time from EEG is not available.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen asesoramiento médico y están sujetas a cambios según lo exija la ley o las pruebas clínicas aplicables de las directrices de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas pólizas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational; therefore, not covered: Surgical treatments for OSA

Investigational; therefore, not covered: Phrenic nerve stimulation for central sleep apnea

Covered when medically necessary: Surgical treatments for OSA

*Procedure code 64568 may be used to bill the Inspire V therapy system.

ICD-10-CM diagnosis codes

Referencias

OSA

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