Latest Review Date : July 2024                                                                                   

Category: Surgical                                                               

POLICY:

For dates of service August 1, 2024, and after:

Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty (UPPP), uvulopharyngoplasty, uvulopalatal flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty ) may be considered medically necessary when treatment options have been discussed with the individual including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive airway Pressure (BIPAP), medications and alternative surgical procedures.  The following conditions and criteria must be met:

• Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center or home study, and there is documentation of an Apnea-Hypopnea Index (AHI) ≥ 15.
• Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller’s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion.

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

• Age ≥ 18 years; AND
• AHI ≥ 15 ≤100 with ≤ 25% central apneas; AND
• CPAP failure AND
• Body mass index ≤ 35 kg/m²; AND
• Absence of complete concentric collapse at the soft palate level.

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, un-desirable 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.

Laser-assisted uvulopalatoplasty (LAUP) may be considered medically necessary when treatment options have been discussed with the individual including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BIPAP), medications and alternative surgical procedures.  The following conditions and criteria must be met:

• Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center or home study, and there is documentation of an Apnea-Hypopnea Index (AHI) ≥ 15.
• Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller’s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion.

Laser-assisted uvulopalatoplasty (LAUP) is considered not medically necessary when used for the treatment of snoring.

Genioglossal advancement, hyoid suspension and myotomy and other mandibular-maxillary advancement (MMA) may be considered medically necessary for the treatment of obstructive sleep apnea when the following criteria are met:  

• AHI > 20 or oxygen desaturations less than 90% as determined by a nocturnal polysomnogram performed in an approved sleep study center or home study
  • Cephalometric abnormalities
  • (Clinically Significant) Hypopharyngeal obstruction
  • CPAP/BIPAP trial over a period of time (unless RDI less than 5 cannot be achieved) or patient has immediate intolerance (true claustrophobic reaction)
  • Otolaryngologist evaluation with appropriate interventions
  • If UPPP performed prior to orthognathic surgery, will need to repeat sleep study demonstrating obstructive sleep apnea

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

Radiofrequency ablation of palatal tissues or radiofrequency volumetric tissue reduction (Somnoplasty) are considered not medically necessary for simple snoring, upper airway resistance syndrome and obstructive sleep apnea syndrome. 

Uvulectomy is considered not medically necessary when used for the treatment of snoring.

Midline glossectomy is considered investigational for the treatment of upper airway obstruction syndrome and obstructive sleep apnea syndrome.

Palatal stiffening procedures, including but not limited to, cautery assisted palatal stiffening operation, and the implantation of palatal implants, are considered not medically necessary in the treatment of snoring alone, and are considered investigational as a treatment for upper airway resistance syndrome or OSA.

Atrial pacing is considered investigational.

Repose tongue suspension system is considered investigational.

Simple snoring in the absence of documented obstructive sleep apnea is not considered a medical condition; therefore, any surgical intervention, such as LAUP, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, are considered not medically necessary.

For dates of service prior to August 1, 2024:

Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty (UPPP), uvulopharyngoplasty, uvulopalatal flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty) may be considered medically necessary when treatment options have been discussed with the individual including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive airway Pressure (BIPAP), medications and alternative surgical procedures.  The following conditions and criteria must be met:

• Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center or home study, and there is documentation of an Apnea-Hypopnea Index (AHI) ≥ 15.
• Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller’s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion.

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

• Age ≥ 22 years; AND
• AHI ≥ 15 with less than 25% central apneas; AND
• CPAP failure AND
• Body mass index ≤ 32 kg/m²; AND
• Non-concentric retropalatal obstruction on drug-induced sleep endoscopy.

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

• Age 10 to 21 years; AND
• AHI >10 and <50 with less than 25% central apneas after prior adenotonsillectomy; AND
• Have either tracheotomy or be ineffectively treated with CPAP due to noncompliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device; AND
• Body mass index ≤ 95^th percentile for age; AND
• Non-concentric retropalatal obstruction on drug-induced sleep endoscopy.

Laser-assisted uvulopalatoplasty (LAUP) may be considered medically necessary when treatment options have been discussed with the individual including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BIPAP), medications and alternative surgical procedures.  The following conditions and criteria must be met:

• Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center or home study, and there is documentation of an Apnea-Hypopnea Index (AHI) ≥ 15.
• Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller’s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion.

Laser-assisted uvulopalatoplasty (LAUP) is considered not medically necessary when used for the treatment of snoring.

Genioglossal advancement, hyoid suspension and myotomy and other mandibular-maxillary advancement (MMA) may be considered medically necessary for the treatment of obstructive sleep apnea when the following criteria are met:  

• AHI > 20 or oxygen desaturations less than 90% as determined by a nocturnal polysomnogram performed in an approved sleep study center or home study
• Cephalometric abnormalities
• (Clinically Significant) Hypopharyngeal obstruction
• CPAP/BIPAP trial over a period of time (unless RDI < 5 cannot be achieved) or patient has immediate intolerance (true claustrophobic reaction)
• Otolaryngologist evaluation with appropriate interventions
• If UPPP performed prior to orthognathic surgery, will need to repeat sleep study demonstrating obstructive sleep apnea

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

Radiofrequency ablation of palatal tissues or radiofrequency volumetric tissue reduction (Somnoplasty) are considered not medically necessary for simple snoring, upper airway resistance syndrome and obstructive sleep apnea syndrome. 

Uvulectomy is considered not medically necessary when used for the treatment of snoring.

Midline glossectomy is considered investigational for the treatment of upper airway obstruction syndrome and obstructive sleep apnea syndrome.

Palatal stiffening procedures, including but not limited to, cautery assisted palatal stiffening operation, and the implantation of palatal implants, are considered not medically necessary in the treatment of snoring alone, and are considered investigational as a treatment for upper airway resistance syndrome or OSA.

Atrial pacing is considered investigational.

Repose tongue suspension system is considered investigational.

Simple snoring in the absence of documented obstructive sleep apnea is not considered a medical condition; therefore, any surgical intervention, such as LAUP, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, are considered not medically necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. For individuals who have failed conservative therapy, established surgical approaches may be indicated. This evidence review addresses minimally invasive surgical procedures for the treatment of OSA. They include laser-assisted uvuloplasty, tongue base suspension, radiofrequency volumetric reduction of palatal tissues and base of tongue, palatal stiffening procedures, and hypoglossal nerve stimulation. This evidence review does not address conventional surgical procedures such as uvulopalatopharyngoplasty (UPPP), hyoid suspension, surgical modification of the tongue, maxillofacial surgery, or adenotonsillectomy.

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. 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 individual 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 higher 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 individuals 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.

Terminology and diagnostic criteria for OSA are shown in Table 1.

Table 1. Terminology and Definitions for Obstructive Sleep Apnea

Terms	Definition
Respiratory event
Apnea	The frequency of apneas and hypopneas is measured from channels assessing oxygen desaturation, respiratory airflow, and respiratory effort. In adults, apnea is defined as a drop in airflow by 90% or more of pre-event baseline for at least 10 seconds. 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.
Hypopnea	Hypopnea in adults is scored when the peak airflow drops by at least 30% of pre-event baseline for at least 10 seconds in association with either at least 4% arterial oxygen desaturation or an arousal. Hypopneas in children are scored by a 50% or greater drop in nasal pressure and either a 3% or more decrease in oxygen saturation or an associated arousal.
RERA	Respiratory event-related arousal is defined as an event lasting at least 10 seconds associated with flattening of the nasal pressure waveform and/or evidence of increasing respiratory effort, terminating in an arousal but not otherwise meeting criteria for apnea or hypopnea
Respiratory event reporting
AHI	The  average number of apneas or hypopneas per hour of sleep
RDI	The respiratory disturbance index is the number of apneas, hypopneas, or respiratory event-related arousals per hour of sleep time. RDI is often used synonymously with the AHI.
REI	The respiratory event index is the number of events per hour of monitoring time. Used as an alternative to AHI or RDI in home sleep studies when actual sleep time from EEG is not available.
Diagnosis
OSA	Obstructive sleep apnea is repetitive episodes of upper airway obstruction due to the collapse and obstruction of the upper airway during sleep
Mild OSA	In adults: AHI or RDI of 5 to <15 In children: AHI ≥1.0 to <5
Moderate OSA	AHI or RDI of 15 to < 30; Children: AHI of ≥ 5 to <10
Severe OSA	Adults: AHI or RDI ≥30 Children: AHI of ≥10
Treatment
Positive airway pressure (PAP)	Positive airway pressure may be continuous (CPAP) or auto-adjusting (APAP) or Bi-level (Bi-PAP).
PAP failure	Usually defined as an AHI >20 events per hour while using CPAP
PAP intolerance	CPAP use for <4 hours per night for ≥5 nights per week, or refusal to use CPAP. CPAP intolerance may be observed in patients with mild, moderate, or severe OSA

AHI: Apnea/Hypopnea Index; APAP:auto-adjusting positive airway pressure; Bi-PAP: Bi-level positive airway pressure; CPAP: continuous positive airway pressure; EEG: electroencephalogram; OSA: obstructive sleep apnea; PAP: positive airway pressure; RDI: Respiratory Disturbance Index;REI: Respiratory Event Index; RERA: respiratory event-related arousal

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was performed through May 6, 2024.

Summary of Evidence:

For individuals who have OSA who receive laser-assisted uvulopalatoplasty, the evidence includes a single randomized controlled trial (RCT). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The trial indicates reductions in snoring, but limited efficacy on the Apnea/Hypopnea Index (AHI) or symptoms in patients with mild-to-moderate OSA. 

For individuals who have OSA who receive a radiofrequency volumetric reduction of palatal tissues and base of tongue, the evidence includes 2 sham-controlled randomized trials and a prospective, single-arm cohort study. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. 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 that the technology results in an improvement in the net health outcome.

For individuals who have OSA who receive palatal stiffening procedures, the evidence includes two sham-controlled randomized trials. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. 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 the results of the more successful trial and, if successful, define the appropriate selection criteria. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OSA who receive tongue base suspension, the evidence includes a feasibility RCT with 17 patients. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The single RCT compared tongue suspension plus uvulopalatopharyngoplasty with tongue advancement plus 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 uvulopalatopharyngoplasty improves the net health outcome. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have OSA who receive hypoglossal nerve stimulation, the evidence includes systematic reviews, 3 RCTs, nonrandomized prospective studies, nonrandomized studies with historical controls, and prospective single-arm studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. A double-blind, multicenter RCT of 89 adults with moderate-to-severe OSA who did not tolerate CPAP found significant short-term improvement in AHI, ESS, and quality of life measures with hypoglossal nerve stimulator (HNS) compared to sham stimulation. The study was limited by a short duration of follow-up and lack of diversity among 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, as well as a lack of a true control group for long-term outcomes. Hypoglossal nerve stimulation has shown success rates for about two-thirds of a subset of patients who met selection criteria that included AHI, BMI (≤32 or ≤35 kg/m²), and favorable pattern of palatal collapse across nonrandomized trials. These results were maintained out 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. The study of 42 individuals with Down Syndrome and OSA found a success rate of 73.2% with 4 device extrusions corrected with replacement surgery. Limitations of the current evidence base preclude determination of who is most likely to benefit from this invasive procedure. 

Practice Guidelines and Position Statements

American Academy of Sleep Medicine

The American Academy of Sleep Medicine (AASM, 2021) published practice guidelines on when to refer patients for surgical modifications of the upper airway for OSA. These guidelines replaced the 2010 practice parameters for surgical modifications.  The AASM guidelines note that positive airway pressure (PAP) is the most efficacious treatment for OSA, but effectiveness can be compromised when patients are unable to adhere to therapy or obtain adequate benefit, which is when surgical management may be indicated. The AASM guideline recommendations are based on a systematic review and meta-analysis of 274 studies of surgical interventions, including procedures such as uvulopalatopharyngoplasty (UPPP), modified UPPP, MMA, tongue base suspension, and hypoglossal nerve stimulation.  The systematic review deemed most included data of low quality, consisting of mostly observational data. The AASM strongly recommend that clinicians discuss referral to a sleep surgeon with adults with OSA and body mass index (BMI) 35) who are intolerant or unaccepting of PAP, the AASM strongly recommends discussion of referral to a bariatric surgeon, along with other weight loss strategies.

American Academy of Pediatrics

The American Academy of Pediatrics (AAP) published a 2012 clinical practice guideline on the diagnosis and management of childhood OSA.  AAP recommends that if a child has OSA, a clinical examination consistent with adenotonsillar hypertrophy, and does not have a contraindication to surgery, the clinician should recommend adenotonsillectomy as the first line of treatment. AAP recommends that patients should be referred for CPAP management if symptoms/signs or objective evidence of OAS persists after adenotonsillectomy or if adenotonsillectomy is not performed. Weight loss should be recommended in addition to other therapy if a child/adolescent with OSA is overweight or obese(defined as BMI >95th percentile).

American Academy of Otolaryngology‒Head and Neck Surgery

The American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS; 2014) has a revised position statement on surgical management of OSA. Procedures AAO-HNS supported as effective and not considered investigational when part of a comprehensive approach in the medical and surgical management of adults with OSA include:

• tracheotomy
• nasal and pharyngeal airway surgery,
• tonsillectomy and adenoidectomy,
• palatal advancement,
• uvulopalatopharyngoplasty,
• genioglossal advancement,
• hyoid myotomy,
• midline glossectomy,
• tongue suspension,
• maxillary and mandibular advancement.

In a 2021 position statement, AAO-HNS supported hypoglossal nerve stimulation as an effective second-line treatment of moderate-to-severe OSA.

American Society for Metabolic and Bariatric Surgery

In 2012, the American Society for Metabolic and Bariatric Surgery published guidelines on the perioperative management of OSA.  The guideline states that OSA is strongly associated with obesity with the incidence of OSA in the morbidly obese population being reported to be between 38% and 88%. They recommend bariatric surgery be the initial treatment of choice for OSA in this population, as opposed to surgical procedures directed at the mandible or tissues of the palate.

National Institute for Health and Care Excellence

National Institute for Health and Care Excellence (NICE) 2017 guidance concluded that evidence on the safety and efficacy of hypoglossal nerve stimulation is limited in quantity and quality, and the procedure should only be used in the context of a clinical trial.

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Uvulopalatopharyngoplasty, UPPP, UP-3, laser-assisted palatoplasty, LAUP, somnoplasty, radiofrequency ablation, uvulectomy, genioglossal advancement, hyoid suspension and myotomy, maxillomandibular advancement, palatal implants, Pillar™, snoring, cautery-assisted palatal stiffening, atrial pacing, ApniCure, Inspire II Upper Airway Stimulation System, hypoglossal nerve stimulation, Adenotonsillectomy, Genio, aura6000

APPROVED BY GOVERNING BODIES:

The regulatory status of minimally invasive surgical interventions is shown in Table 2.

Table 2. Minimally Invasive Surgical Interventions for Obstructive Sleep Apnea

Interventions	Devices (predicate or prior name)	Manufacturer (previously owner)	Indication	PMA/ 510(k)	Year	FDA Product Code
LAUP	Various
Radiofrequency ablation	Somnoplasty®		Simple snoring and for the base of the tongue for OSA	K982717	1998	GEI
Palatal Implant	Pillar® Palatal Implant	Pillar Palatal (Restore Medical/ Medtronic)	Stiffening the soft palate which may reduce the severity of snoring and incidence of airway obstructions in patients with mild-to-moderate OSA	K040417	2004	LRK
Tongue base suspension	AIRvance® (Repose)	Medtronic	OSA and/or snoring. The AlRvance TM Bone Screw System is also suitable for the performance of a hyoid suspension	K122391	1999	LRK
Tongue base suspension	Encore™ (PRELUDE III)	Siesta Medical	Treatment of mild or moderate OSA and/or snoring	K111179	2011	ORY
Hypoglossal nerve stimulation	Inspire® (Inspire II® Upper Airway Stimulation)	Inspire Medical Systems	Patients ≥ 18 years with AHI ≥15and ≤100 who have failed (AHI >15 despite CPAP usage) or cannot tolerate (<4 h use per night for ≥5nights per week) CPAP and do not have complete concentric collapse at the soft palate level. Patients between ages 18 and 21 should also be contraindicated for or not effectively treated by adenotonsillectomy.Inspire is also indicated in pediatric patients ages 13 to 18 years with Down Syndrome and severe sleep apnea (AHI >10 and <50).	P130008, S039	2014	MNQ
Hypoglossal nerve stimulation	aura6000®	LivaNova (ImThera Medical)		IDE	2014
Hypoglossal nerve stimulation	Genio™	Nyxoa		European CE Mark	2019

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 age 18 to 21 was based on patients with Down Syndrome and is contingent on a post-approval study of the Inspire® UAS in this age group. The post-approval study will be a multicenter, single-arm, prospective registry with 60 pediatric patients age 18 to 21. Visits will be scheduled at pre-implant, post-implant, 6 months, and yearly thereafter through 5 years.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING:

CPT Codes:

21120	Genioplasty; augmentation (autograft, allograft, prosthetic material)
21121	Genioplasty; sliding osteotomy, single piece
21122	Genioplasty; sliding osteotomies, two or more osteotomies (e.g., wedge excision or bone wedge reversal for asymmetrical chin)
21123	Genioplasty; sliding, augmentation with interpositional bone grafts (includes obtaining autografts)
21199	Osteotomy, mandible, segmental with genioglossal advancement
21299	Unlisted craniofacial and maxillofacial procedure
21685	Hyoid myotomy and suspension
41120	Glossectomy; less than one-half tongue
41130	Glossectomy; hemiglossectomy
41512	Tongue base suspension, permanent suture technique
41530	Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session
42120	Resection of palate or extensive resection of lesion
42140	Uvulectomy, excision of uvula
42145	Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty, uvulopharyngoplasty)
42299	Unlisted procedure, Palate or Uvula
42820-42821	Tonsillectomy and adenoidectomy, code range
42825-42826	Tonsillectomy, primary or secondary, code range
42830-42831	Adenoidectomy, primary, code range
42835-42836	Adenoidectomy, secondary, code range
42950	Pharyngoplasty (plastic or reconstructive operation on pharynx)
64568	Open implantation of cranial nerve (e.g., vagus nerve) neurostimulator electrode array and pulse generator
64569	Revision Or Replacement of Cranial Nerve (E.g., Vagus Nerve) Neurostimulator Electrode Array, Including Connection To Existing Pulse Generator
64570	Removal of Cranial Nerve (E.g., Vagus Nerve) Neurostimulator Electrode Array and Pulse Generator
64582	Hypoglossal nerve neurostimulator implantation; open (Effective 01/01/2022)
64583	Hypoglossal nerve neurostimulator revision or replacement (Effective 01/01/2022)
64584	Hypoglossal nerve neurostimulator removal (Effective 01/01/2022)
95976	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with simple cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional
95977	Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with complex cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional

HCPCS Codes:

S2080

Laser-assisted Uvulopalatoplasty (LAUP)

REFERENCES:

1. American Academy of Otolaryngology - Head and Neck Surgery. Surgical Management of Obstructive Sleep Apnea. 2014; www.entnet.org/Practice/policySurgicalMgmtApnea.cfm. 
2. American Academy of Otolaryngology-Head and Neck Surgery. 2016 Position Statement: Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea (OSA). www.entnet.org/content/position-statement-hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osa. 
3. American Academy of Otolaryngology-Head and Neck Surgery. 2019 Position Statement: Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea (OSA) http://www.entnet.org/content/positionstatement- hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osa. 
4. American Society for Metabolic & Bariatric Surgery. Peri-operative management of obstructive sleep apnea. 2012; //asmbs.org/2012/03/peri-operative-management-of-obstructive-sleep-apnea/.
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14. Eastwood PR, Barnes M, Walsh JH et al. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep 2011; 34:1479-1486.
15. Gillespie MB, Soose RJ. et al. Upper Airway Stimulation for Obstructive Sleep Apnea: Patient-Reported Outcomes after 48 Months of Follow-up. Otolaryngol Head Neck Surg. April 2017, 156(4):765-771.
16. Handler E, Hamans E, Goldberg AN, et al. Tongue suspension: an evidence-based review and comparison to hypopharyngeal surgery for OSA. Laryngoscope. Jan 2014; 124(1):329-336.
17. Hasselbacher, KK, Hofauer, BB, Maurer, JJ, Heiser, CC, Steffen, AA, Sommer, JJ. Patient-reported outcome: results of the multicenter German post-market study. Eur Arch Otorhinolaryngol, 2018 May 29;275(7).
18. Heiser C, Maurer JT, Hofauer B, et al. Outcomes of upper airway stimulation for obstructive sleep apnea in a multicenter German postmarket study. Otolaryngol Head Neck Surg. Feb 2017;156(2):378-384.
19. Herman H, Stern J, Alessi DM, et al. Office-Based Multilevel Radiofrequency Ablation for Mild-to-Moderate Obstructive Sleep Apnea.OTO Open. 2023; 7(1): e19.
20. Huntley C, Chou DW, Doghramji K, et al. Comparing upper airway stimulation to expansion sphincter pharyngoplasty: a single university experience. Ann Otol Rhinol Laryngol. Jun 2018;127(6):379-383.
21. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
22. Kezirian EJ, Goding GS, Jr., Malhotra A, et al. Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. J Sleep Res. Feb 2014; 23(1):77-83.
23. Kim DH, Kim SW, Han JS, et al. Comparative effectiveness of hypoglossal nerve stimulation and alternative treatments for obstructive sleep apnea: a systematic review and meta-analysis. J Sleep Res. May 2024; 33(3): e14017.
24. Liu P, Kong W, Fang C, et al. Hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea: A systematic review and meta-analysis. Front Neurol. 2022; 13: 1037926.
25. Marcus CL, Brooks LJ, Draper KA, et al. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics 2012; 130(3):e714-55. //pediatrics.aappublications.org/content/130/3/576.full.pdf+html?sid=d61600bf-6989-4879-8d96-13f0421d186a.
26. Maurer JT, Sommer JU, Hein G, et al. Palatal implants in the treatment of obstructive sleep apnea: a randomized, placebo-controlled single-centre trial. Eur Arch Otorhinolaryngol. Jul 2012; 269(7):1851-1856.
27. Mehra R, Steffen A, Heiser C, et al. Upper Airway Stimulation versus Untreated Comparators in Positive Airway Pressure Treatment-Refractory Obstructive Sleep Apnea. Ann Am Thorac Soc. Dec 2020; 17(12): 1610-1619.
28. National Institute for Health and Care Excellence. Hypoglossal nerve stimulation for moderate to severe obstructive sleep apnoea (IPG598). 2017. https://www.nice.org.uk/guidance/ipg598/chapter/1Recommendations. 
29. Neruntarat C. Long-term results of palatal implants for obstructive sleep apnea. Eur Arch Otorhinolaryngol. Jul 2011; 268(7):1077-1080.
30. Patel RM, Wang HZ, Jamro EL, et al. Response to Hypoglossal Nerve Stimulation Changes With Body Mass Index and Supine Sleep. JAMA Otolaryngol Head Neck Surg. May 01 2024; 150(5): 421-428.
31. Roland PS, Rosenfeld RM, Brooks LJ, et al. Clinical practice guideline: Polysomnography for sleep-disordered breathing prior to tonsillectomy in children. Otolaryngol Head Neck Surg. Jul 2011; 145(1 Suppl):S1-15.
32. Schwartz AR, Barnes M, Hillman D et al. Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea. Am J Respir Crit Care Med 2012; 184(4): 420-426.
33. Schwartz AR, Jacobowitz O, Eisele DW, et al. Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Apr 06 2023.
34. Shah J, Russell JO, Waters T, et al. Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience. Am J Otolaryngol. May - Jun 2018;39(3):266-270.
35. Soose RJ, Woodson BT, Gillespie MB, et al. Upper airway stimulation for obstructive sleep apnea: self-reported outcomes at 24 months. J Clin Sleep Med. Jan 2016; 12(1):43-48.
36. Steffen A, Sommer JU, Hofauer B, et al. Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. Laryngoscope. Feb 2018;128(2):509-515.
37. Steffen A, Sommer UJ, Maurer JT, et al. Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea. Sleep Breath. Sep 2020; 24(3): 979-984.
38. Strollo PJ, Jr., Gillespie MB, Soose RJ, et al. Upper airway stimulation for obstructive sleep apnea: durability of the treatment effect at 18 months. Sleep. 2015; 38(10):1593-1598.
39. Strollo PJ, Jr., Soose RJ, Maurer JT, et al. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. Jan 9 2014; 370(2):139-149.
40. Suurna MV, Steffen A, Boon M, et al. Impact of Body Mass Index and Discomfort on Upper Airway Stimulation: ADHERE Registry 2020Update. Laryngoscope. Nov 2021; 131(11): 2616-2624.
41. Thaler E, Schwab R, Maurer J, et al. Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy. Laryngoscope. May 2020; 130(5): 1333-1338.
42. Van de Heyning PH, Badr MS, Baskin JZ et al. Implanted Upper Airway Stimulation Device for Obstructive Sleep Apnea. Laryngoscope 2012; 122:1626-1633.
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46. Woodson BT, Strohl KP, Soose RJ et al. Upper Airway Stimulation for Obstructive Sleep Apnea: 5- Year Outcomes. Otolaryngol Head Neck Surg. 2018. 1-9.
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POLICY HISTORY:

Medical Policy Panel, May 2015

Medical Policy Group, January 2016 (6):  Policy adopted and all information pertaining to Surgical treatment of snoring and obstructive sleep apnea transferred from medical policy #065 – Management of Obstructive Sleep Apnea to this policy.

Medical Policy Group, August 2016 (6): Policy posted, no change to medical policy statement.

Medical Policy Administration Committee, August 2016

Medical Policy Group, December 2016 : 2017 Annual Coding Update. Added new cpt codes 0466T – 0468T to Current Coding.

Medical Policy Group, December 2016 (6): Removed “not a home study” from the policy statement. Added reference to medical policy #305 for guidelines for polysomnography testing.

Medical Policy Panel, December 2016

Medical Policy Group, January 2017 (6): Updates to Description, added Adenotonsillectomy to policy statement and palatopharyngoplasty to policy statement, Key Points, Key Words, Coding, and References.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (6): Updates to Description, Key Points, Practice Guidelines, Coding and References.

Medical Policy Panel, December 2018

Medical Policy Group, January 2019 (6): Updated policy statement for Genioglossal advancement, hyoid suspension and myotomy, and other mandibular-maxillary advancement procedures to include "home study".

Medical Policy Group, February 2019 (6): Updates to Description, Policy Statement to include coverage for HNS, Key Points, Coding (64569/64570) Practice Guidelines, Governing Bodies and References.

Medical Policy Group, March 2019 (6) DRAFT extended to 04/01/19.

Medical Policy Group, April 2019 (6): DRAFT ended 04/01/19, AHI requirement for hypoglossal nerve stimulator changed to ≥15 for adult criteria. See Policy statement.

Medical Policy Panel, June 2019

Medical Policy Group, July 2019 (6): Updates to Key Points and References.

Medical Policy Panel, June 2020

Medical Policy Group, July 2020 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines, Key Words (Genio, aura6000) and References. No change to policy intent.

Medical Policy Group, October 2020 (6): Expanded policy statement for Palatopharyngoplasty to include (e.g., uvulopalatopharyngoplasty (UPPP), uvulopharyngoplasty, uvulopalatal flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty ).

Medical Policy Group, December 2020 (6): Updated Coding to include 42950.

Medical Policy Group, April 2021 (6): Updated Governing Bodies and Coding to include 95976/95977.

Medical Policy Panel, June 2021

Medical Policy Group, June 2021 (6): Updates to Key Points and References (removed references prior to 2010). Policy statement updated to remove “not medically necessary,” or “investigational”, no change to policy intent.

Medical Policy Group, November 2021:  2022 Annual Coding Update.  Added CPT 64582-64584 to the Current coding section. 0466T-0468T moved to the Previous Coding section, Revised 64568.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines and References.

Medical Policy Group, March 2023 (6): Removed “Provent/EPAP” from Key Words.

Medical Policy Panel, June 2023

Medical Policy Group, June 2023 (6): Updates to Description, Key Points, Governing Bodies, Benefit Application and References.

Medical Policy Panel, July 2024

Medical Policy Group, July 2024 (6): Updates to Policy statement, HGNS criteria changes, Key Points, Governing Bodies, Practice Guidelines and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.