| Coverage Policy Manual | |
| Policy #: | 2015035 |
| Category: | Surgery |
| Initiated: | December 2015 |
| Last Review: | September 2023 |
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| Sleep Apnea, Minimally Invasive Surgical Treatment | |
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| Description: |
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 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 (ie, 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 also 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 (Dudley, 2016). 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<.001) and Black race (p=.020) were independently associated with a decreased likelihood of receiving surgery for sleep apnea (Cohen, 2022). Lee et al found that Black men had a continuous mortality increase specifically related to OSA over the study period (1999 to 2019; annual percentage change 2.7%; 95% confidence interval, 1.2 to 4.2) compared to any other racial group (Lee, 2022).
Terminology and Definitions for Obstructive Sleep Apnea
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% of the pre-event baseline for at least 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 - 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 desaturation (depending on the scoring criteria) or arousal. Hypopneas in children are scored by a ≥50% drop in nasal pressure and either a ≥3% decrease in oxygen saturation or 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 increased respiratory effort, terminating in arousal but not otherwise meeting criteria for apnea or hypopnea
Respiratory event reporting:
Apnea/Hypopnea Index (AHI) - The average number of apneas or hypopneas per hour of sleep
Respiratory Disturbance Index (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.
Respiratory event index (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:
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 criterion 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.
OSA - Repetitive episodes of upper airway obstruction due to the collapse and obstruction of the upper airway during sleep
Mild OSA - In adults: AHI of 5 to <15. In children: AHI ≥1 to 5
Moderate OSA - AHI of 15 to < 30. Children: AHI of > 5 to 10
Severe OSA – Adults: AHI ≥30. Children: AHI of >10
A condition related to OSA has been termed upper airway resistance syndrome. 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 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 CPAP has also been used to support the diagnosis.
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 greater than 20 events per hour while using PAP
PAP Intolerance - PAP use for less than 4 h per night for 5 nights or more per week, or refusal to use CPAP. CPAP intolerance may be observed in patients with mild, moderate, or severe OSA
Nonsurgical treatment for OSA or UARS includes CPAP or orthodontic repositioning devices, which are addressed in a separate policy. Traditional surgeries for OSA or UARS include UPPP and a variety of maxillofacial surgeries such as 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 and addressed in this policy include the following.
Laser-Assisted Uvulopalatoplasty
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 from standard UPPP, because 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 of Palatal Tissues and the Tongue
Radiofrequency ablation (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.
Hypoglossal Nerve Stimulation
Stimulation of the hypoglossal nerve results in contraction of the genioglossus muscle, the largest upper airway dilator muscle. This causes tongue protrusion and stiffening of the anterior pharyngeal wall, potentially leading to a decrease in apneic events. Hypoglossal nerve stimulation systems include an implantable neurostimulator, stimulating leads, and electrodes. Intermittent stimulation systems also include respiratory sensing leads.
Regulatory Status
Minimally Invasive Surgical Interventions for Obstructive Sleep Apnea:
Coding
Effective January 01, 2017, there are CPT codes available for the use of insertion, revision, replacement and removal of hypoglossal nerve stimulation sensory electrodes.
0466T Insertion of chest wall respoiratory sensor electrode or electrode array, including connection to pulse generator
0467T Revision or replacement of chest wall respiratory sensor electrode or electrode array, including connection to existing pulse generator
0468T Removal of chest wall respiratory sensor electrode or electrode array
Related Policies:
2009019 Sleep Apnea, Testing
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Policy/ Coverage: |
EFFECTIVE AUGUST 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
IMPLANTABLE HYPOGLOSSAL NERVE STIMULATORS
Hypoglossal nerve stimulators meet primary coverage criteria of effectiveness in adults with OSA when ALL of the following criteria are met:
Hypoglossal nerve stimulation meets primary coverage criteria of effectiveness in adolescents or young adults with Down syndrome and OSA under the following conditions:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The following minimally-invasive surgical procedures do not meet member benefit certificate primary coverage criteria for the treatment of OSA, upper airway resistance syndrome (UARS), snoring or any other indication:
For members with contracts without primary coverage criteria, the minimally-invasive techniques outlined above are considered investigational for the treatment of OSA or upper airway resistance syndrome (UARS), snoring or any other indication. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
EFFECTIVE PRIOR to AUGUST 2019
The following minimally-invasive surgical procedures do not meet member benefit certificate primary coverage criteria for the treatment of OSA, upper airway resistance syndrome (UARS), snoring or any other indication:
For members with contracts without primary coverage criteria, the minimally-invasive techniques outlined above are considered investigational for the treatment of OSA or upper airway resistance syndrome (UARS), snoring or any other indication. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
Laser-Assisted Uvulopalatoplasty
Ferguson et al reported on a trial that randomized 45 subjects with mild-to-moderate sleep apnea (defined as an AHI ranging between 10-27 per hour) to either uvulopalatoplasty (LAUP) or no treatment (Ferguson, 2003).
The LAUP procedure was repeated at 1- to 2-month intervals until either the snoring was significantly reduced, no more tissue could safely be removed, or the patient refused further procedures. The primary outcome measurement was the reduction in AHI in the LAUP group versus the control group. An AHI of less than 10 was considered a successful treatment. In the treatment group, 24% were considered treatment successes and 76% were failures. In the control group (who received no therapy), 16.7% were considered treatment successes. The authors concluded that LAUP can be effective in some patients, but the reduction in AHI and the level of symptomatic improvement were minor overall.
Tongue Suspension
In 2013, Handler et al reported a systematic review of tongue suspension versus hypopharyngeal surgery for the treatment of OSA (Handler, 2014). The review included 27 studies reporting on 4 separate procedures; tongue uspension alone, tongue suspension plus UPPP, genioglossus advancement (GA) plus UPPP, and genioglossus advancement plus hyoid suspension (GAHM) plus UPPP. A successful treatment was defined as a 50% decrease in the RDI or AHI and a postoperative RDI or AHI less than 20. Tongue suspension alone (6 studies, 82 patients) had a success rate of 36.6%, while the success rate of tongue suspension plus UPPP (8 studies, 167 patients) was 62.3%. A success rate of 61.1% was found for GA plus UPPP (7 studies, 151 patients) and for GAHM plus UPPP (12 studies, 467 patients). The adverse effects of tongue suspension appear to be milder than GA or GAHM and are reversible. Most studies identified in this review were level IV evidence (case series).
One level II RCT included in the systematic review compared 2 tongue base surgeries (RFA or tongue-base suspension) combined with UPPP for moderate to severe sleep apnea (AHI ≥15) (Fernandez-Julian, 2009). In the tongue suspension plus UPPP group (n=28), the mean AHI decreased from 33.1 to 15.1 events per hour. The success rate for the combined procedure (defined as a ≥50% reduction, final AHI <15, and ESS <11) was 57.1%, compared with a success rate of 51.7% in the UPPP plus RFA group (p=0.79). BMI was the main predictor of success, with a success rate for tongue base suspension plus UPPP of only 10% in patients with a BMI between 30 and 35 kg/mg2. Morbidity and complications were higher with the tongue suspension procedure compared with RFA.
RCTs are needed to determine whether adding tongue suspension to UPPP improves the net health outcome compared with treatment with UPPP alone.
Radiofrequency Volumetric Reduction of Palatal Tissues and Base of Tongue
In 2008, Farrar et al published a meta-analysis of RFA for the treatment of OSA in patients with a RDI of 5 or more (Farrar, 2008). Sixteen studies met the inclusion criteria; 3 were randomized and 13 were nonrandomized.
Six studies treated both the base of the tongue and the soft palate, 2 treated the soft palate only, and 8 ablated the base of the tongue only. The population was in the overweight, but not obese, category, with a mean BMI of 28.5. In half of the studies, the average baseline RDI was less than 30, and in 6 of the studies, the average baseline ESS was less than 10. The meta-analysis indicated a 31% reduction in both ESS and RDI. The lowest oxygen saturation level was not improved by RFA. The mean number of treatments required for patient satisfaction was 3.7 for the soft palate, 4.3 for the base of the tongue, and 4.8 for both sites (range, 3-7). Complications were noted in 4% of patients; 2 tongue abscesses progressed to airway obstruction requiring tracheotomy. Only 2 of the studies provided 2-year follow-up, with a 32% reduction in ESS and a 45% reduction in RDI. The number of patients who were successfully treated (eg, 50% reduction in RDI) was not reported. This meta-analysis is limited by the inclusion of poor quality uncontrolled studies. Higher quality studies are described next.
A single-blinded RCT of single-stage radiofrequency surgery of the soft palate was reported in 2009 (Back, 2009). Thirty-two patients with mild OSA (AHI between 5 and 15), habitual snoring, and excessive daytime sleepiness according to subjective patient history, were randomized to a single session of RFA or sham ablation. There was no difference between the groups for baseline to posttreatment (4-6 months) changes in the ESS (3-point improvement in ESS for both groups), reports of snoring (1-point improvement in both groups), AHI (no clinically significant change), or any other outcome measure. None of the patients reported any treatment-related symptoms or complications 4 months after treatment. Results of this small single-blinded RCT indicate that single-stage RFA of the soft palate is not effective for the treatment of mild OSA.
An RCT from 2009 compared efficacy and adverse effects of 2 tongue-based procedures (RFA or tongue-base suspension) when combined with UPPP in 57 patients with moderate-to-severe sleep apnea (AHI ≥15) (Fernandez-Julian, 2009). Patients with a BMI of 35 kg/m2 or greater were excluded. Although interpretation of results is limited by the lack of a control group treated with UPPP alone, the success rate for combined RFA + UPPP (defined as a ≥50% reduction and final AHI <15) was 51%. BMI was the main predictor of success, with success rates of only 12.5% in patients with a BMI between 30 and less than 35 kg/mg2. A 2008 retrospective cohort study assessed the incremental value of RFA of the tongue in combination with UPPP (van den Broek, 2008). All patients with both palatal and retroglossal obstruction, an RDI between 5 and 50, and no previous OSA surgery were included in the study. Seventy-five patients meeting the inclusion criteria had been treated with UPPP during the 3-year period, 38 had UPPP alone, 37 had UPPP plus RFA. The groups were comparable for age, sex, BMI, AHI, and mean arterial oxygen saturation (SaO2); however, no details were provided regarding the choice of procedure. With surgical success rate defined as more than 50% reduction of the AHI and AHI below 20, the success rate was 42% with UPPP alone and 49% with RFA (not significantly different). Two patients had an additional RFA treatment. No major complications were observed. The study concluded that the addition of RFA to UPPP resulted in only limited improvement, but there was no major downside to it.
A 2003 study by Woodson et al compared the use of multilevel RFA with the current criterion standard of continuous positive airway pressure (CPAP) in an RCT (Woodson, 2003). The study included patients with mild obesity levels (BMI ≥34 kg/m2) who had mild to moderate sleep apnea with an AHI between 10 and 30. Statistically significant improvement was noted with RFA and CPAP over placebo in OSA-specific quality of life using the Functional Outcomes of Sleep Questionnaire. However, the small size of the trial resulted in most outcomes not being statistically significant. The same group of authors reported a further subgroup analysis from the same trial, focusing on the 26 patients randomized to the RFA arm of the trial to determine whether additional treatments improved outcomes (Steward, 2004). Specifically, the authors focused on multilevel treatments on various combinations of palatal and tongue tissues. Greater improvements in quality of life were reported for those patients who had a total of 5 treatments compared with 3. Another analysis focused on multilevel treatments in 26 patients (Steward, 2004). This subgroup likely contains overlapping patients with the previous report, and the results were similar (ie, greater improvements were reported in those patients who had a total of 5 treatments).
Palatal Stiffening Procedures
Cautery-Assisted Palatal Stiffening Operation
There is limited evidence regarding cautery-assisted palatal stiffening operation (CAPSO) in patients with clinically significant OSA; most studies on CAPSO focus on patients with simple snoring (AHI <5) or mild sleep apnea (AHI <15) (Mair, 2000; Pang, 2007). In 2000, Wassmuth et al reported a case series of 25 patients with OSA who underwent CAPSO (Wassmuth, 2000). Responders were defined as patients who had a reduction in AHI of at least 50%. Mean AHI improved from 25.1±12.9 to 16.6±15.0. The broad confidence intervals limit interpretation of these data.
Palatal Implants
In a 2008 trial by Steward et al, 100 patients with mild to moderate OSA and suspected retropalatal obstruction were randomly assigned to palatal implants or sham placebo (Steward, 2008). Patients with BMI greater than 32 kg/m2 were excluded from the study. About 1000 patients were evaluated to identify the 100 study patients. At 3-month follow-up, the average AHI increased in both groups from a baseline of about 17, although the increase was greater in the placebo group (8.9 vs 2.9, respectively). A reduction in AHI by at least 50% or to below 20 was more common in the implant group (26% vs 10%, respectively; p=0.05). Improvement in ESS did not differ from that of sham (p=0.62). Partial implant extrusion occurred in 2 patients (4%).
Friedman et al reported an industry-sponsored randomized double-blind, sham-controlled trial of palatal implants in 62 patients with symptoms of OSA (Friedman, 2008). Other inclusion criteria included: Friedman tongue position I, II, or III; diagnosis of mild to moderate OSA (AHI ≥5 and <40) on baseline polysomnography (PSG); a soft palate of 2 cm or more but less than 3.5 cm; and BMI less than 32 kg/m2. AHI at baseline was 23.8 events per hour in the implant group and 20.1 in controls. Seven patients did not return for repeat PSG and were considered treatment failures in the intention-to-treat analysis. At 3-month followup, the AHI improved to 15.9 events per hour in the implant group but did not change significantly in the controls (21.0). The ESS improved from 12.7 to 10.2 in the implant group and did not change significantly in the controls (11.7 to 11.1). With success defined as an AHI reduction of 50% or more and AHI less than 20, palatal implantation resulted in the successful treatment of 41.9% of implanted patients compared with 0% of controls. Two patients had partial implant extrusion.
In 2012, Maurer et al reported a randomized double-blind, sham-controlled trial of the Pillar palatal implant in 20 patients with mild to moderate OSA because of palatal obstruction (Maurer, 2012). At 90 days, the AHI in the treatment group improved from 19.1 to 8.2 events per hour and lowest oxygen saturation improved from 82.8% to 88.3%. These measures did not improve significantly in the control group, and there was no significant difference in outcomes between the implant and control groups in this small trial. The ESS did not improve significantly in either group.
There are also uncontrolled series of patients treated with palatal implants. For example, Walker et al published 90-day and 15-month follow-up from a multicenter study on palatal implants (Pillar System) in 63 subjects (Walker, 2006; Walker, 2007). The AHI decreased from a baseline of 25 to 22 in the 53 patients (84%) who were evaluated at 90 days. Twenty-two patients (35%) were available for the follow-up study; 13 had shown a decrease in AHI (from a baseline of 20 to 13) at 90 days. Of these, 10 (77% of the 13) maintained the decrease at 15 months. The 9 patients whose AHI had not improved at 90 days had no subsequent improvement at the extended follow-up. Mean snoring was rated as 8 at baseline (visual analog scale), and 4 at both 90 days and 15 months. Subjective daytime sleepiness measured by the ESS was reduced at 90 days (11 to 7) but returned to a score of 11 at the longer follow-up. In addition to the very large loss to follow-up, questions remain about the clinical significance of a 3- to 7-point improvement in AHI. Neruntarat reported a case series with a minimum of 24-month follow-up (Neruntarat, 2011). This study included 92 patients with mild to moderate OSA (AHI ≤30 with daytime sleepiness or disturbed sleep) who had received palatal implants after failed medical management. At baseline, the mean AHI was 21.7 events per hour, and the lowest oxygen saturation was 87.4%. At mean 28.9-month follow-up, the AHI had decreased to 10.8, and the lowest oxygen saturation improved to 89.2%. Sleep efficiency improved from 80.6% to 87.2%, and the ESS score improved from a mean of 12.3 to 7.9. Implant extrusion occurred in 7 patients (7.6%), and palatal abscess occurred in 1 patient (1.1%).
Section Summary
The literature on palatal implants consists of 3 RCTs and additional case series with medium-term followup.
Evidence from sham-controlled trials shows a statistically significant but modest reduction in AHI and improvement in lowest oxygen saturation compared with placebo, with limited effects on daytime sleepiness. Additional study is needed to determine whether there is a defined subset of patients who might benefit from this procedure. Studies with longer term follow-up are also needed to evaluate the potential for extrusion of the implants at longer time intervals.
Hypoglossal Nerve Stimulation
In 2014, the STAR Trial Group reported 12-month outcomes from a multicenter, single-arm study (NCT01161420, n=126) of the Inspire® Upper Airway Stimulation system (Strollo, 2014). Patients were included if the AHI score from the screening PSG was at least 20 and no more than 50 events per hour. At 12 months after implantation, 66% of the participants met the co-primary outcome of at least a 50% decrease in AHI with a final AHI of less than 20 events per hour, and 75% met the co-primary outcome of a reduction in the Oxygen Desaturation Index score of 25% or more. The median AHI decreased from 29.3 to 9.0 events per hour (mean, 32.0-15.3) and the Oxygen Desaturation Index score (number of times per hour that SaO2 drops by ³4%) decreased from 25.4 to 7.4 events per hour (mean, 29.9-13.9). The mean ESS decreased from 11.6 to 7.0. The first 46 patients who responded to therapy were then randomized to either continued therapy or withdrawal from therapy. After 7 days, AHI of the continued treatment group remained stable from a mean of 7.2 to 8.9 events per hour, whereas the mean AHI in the withdrawal group increased from 7.6 to 25.8. Eighteen percent of participants had temporary tongue weakness and 21% reported tongue soreness, including abrasion, which resulted from stimulation-induced tongue motion over the lower teeth.
A series of 31 patients implanted with the Apnex hypoglossal nerve stimulation system (HGNS®) was reported in 2014 (Kezirian, 2014). Apnex Medical terminated their pivotal study and ceased operations when it was determined that the trial was unlikely to meet its primary end point.
A 2015 systematic review identified 6 case series with a total of 200 patients treated with hypoglossal nerve stimulation (Certal, 2015). No controlled trials were identified. Two series were identified on the Inspire II System and included the STAR trial previously described. Three series were identified with the HGNS system and included the study of 31 patients previously described. One series of 13 patients was identified with the Aura6000 System (ImThera Medical). When data were combined for meta-analysis, AHI and Oxygen Desaturation Index (ODI) improved by a little over 50% (eg, AHI from 44 to 20, ODI from 21 to 10), and the ESS improved from 12 to 7. All of the included studies described minor complications such as tongue weakness, tongue soreness, pain/swelling at the neck incision, fever, and lack of tongue response to stimulation. Of the 200 patients, 9 (4.5%) had serious device-related adverse events that led to removal of the stimulator.
Additional study with RCTs is needed to permit conclusions regarding the effect of this treatment on health outcomes.
Ongoing Clinical Trials
NCT02293746 – This study evaluating the Inspire® Upper Airway Stimulation (UAS) System is a German Post-Market Study. It has a planned enrollment of 60 participants and is scheduled for completion in April 2016.
NCT02263859 ImThera Medical Targeted Hypoglossal Neurostimulation Study #3 (THN3). This study has a planned enrollment of 141 subjects and is scheduled for completion in May 2021.
NCT02413970 Inspire® Upper Airway Stimulation System (UAS): Post-Approval study. This study has a planned enrollment of 127 subjects and is scheduled for completion in Dec 2021.
Practice Guidelines and Position Statements
American Academy of Sleep Medicine
In 2001, the American Academy of Sleep Medicine (AASM) published practice parameters for the use of laser-assisted uvulopalatoplasty, stating that laser-assisted palatoplasty (LAUP) is not recommended for treatment of OSA (Littner, 2000). This position (Guideline) was restated in AASM clinical guidelines for the evaluation, management, and long-term care of OSA in adults, published in 2009 (Epstein, 2009). All other recommendations in the 2009 clinical guidelines for surgical treatment of OSA were consensus-based.
2016 Update
A literature search conducted through November 2016 did not reveal any new published literature that would prompt a change in the coverage statement.
The STAR Trial Group reported long term outcomes of the multicenter trial assessing the Inspire® Upper Airway Stimulation system . Eighteen-month outcomes were reported in 2015 and 2- and 3-year outcomes were reported in 2016 (Strollo, 2015; Woodson, 2016; Soose, 2016).
For the 18-month follow-up PSG, AHI and ODI scores had returned to levels observed at 12 months. Of the original 126 patients enrolled, 116 (92%) completed 36-month follow-up and 98 (78%) patients agreed to 36-month PSG. For the remainder, the last value from the 12- or 18-month PSG was carried forward. Daily use was reported in 81% of patients. AHI was reduced from a median of 28.2 at baseline to 7.3 at 36 months, with 65% of patients meeting the definition of success described above. An AHI less than 5 events per hour was observed in 44% of patients, while an AHI less than 10 was observed in 69% of patients. An ESS score of less than 10 was reported in 15% of patients at baseline compared to 77% at 36 months. A normal Functional Outcomes of Sleep Questionnaire score (>17.9) was reported for 15% of patients at baseline compared to 63% at 36 months. Soft or no snoring as reported by the bed partner increased from 17% at baseline to 80% at 36 months. There was 1 elective device explantation due to insomnia. Tongue abrasions due to tongue movement along the teeth were successfully treated with adjustment of the stimulation or plastic dental guards.
2018 Update
A literature search conducted using the MEDLINE database did not reveal any new information that would prompt a change in the coverage status.
2019 Update
A literature search was conducted through December 2018. There was no new information identified that would prompt a change in the coverage statement.
2019 Update
At the request of the Arkansas Medical Policy Committee, a literature search using the MEDLINE database through July 2019 was renderer and the following is the summary of the key identified literature.
No RCTs have been identified on HNS. Comparative evidence consists of 2 studies that compared HNS with historical controls treated with UPPP or a variant of UPPP (expansion sphincter pharyngoplasty and a third study that compared HNS with transoral robotic surgery. AHI success by the Sher criteria ranged from 87% to 100% in the HNS group compared with 40% to 64% in the UPPP group. Posttreatment ESS was below 10 in both groups. It is not clear from these studies whether the patients in the historical control group were similar to the subset of patients in the HNS group, particularly in regards to the pattern of palatal collapse and from patients who did not return for postoperative PSG. UPPP may not be the most appropriate comparator for HNS, because UPPP is less effective for patients with obstruction arising primarily from the tongue base (the primary target for HNS).
A third study by Yu et al addresses these concerns and compares outcomes for patients who met criteria for both HNS (non-concentric collapse on DISE) and transoral robotic surgery (retroglossal obstruction) (Yu, 2019). When patients with similar anatomic criteria were compared, HNS led to significantly better improvements in AHI, cure rate (defined as AHI < 5) and the percentage of time that oxygen saturation fell below 90%.
Results of prospective single-arm studies show AHI success rates in 66% to 68% of patients who had moderate-to-severe sleep apnea and a favorable pattern of palatal collapse. Mean AHI was 31 to 32 at baseline, decreasing to 14 to 15 at 12 months. ESS scores decreased to 6.5 to 7.0. All improvements were maintained through 5 years of follow-up. Discomfort due to the electrical stimulation and tongue abrasion were initially common, but were decreased when stimulation levels were reduced. In the post-market study, a normal ESS score (< 10) was obtained in 73% of patients. A FOSQ score of at least 19 was observed in 59% of patients compared to 13% at baseline. At the 12 month follow-up, 8% of bed partners regularly left the room due to snoring, compared to 75% of bed partners at baseline. The average use was 5.6 + 2.1 h per night. Use was correlated with the subjective outcomes, but not with AHI response.
American Academy of Otolaryngology - Head and Neck Surgery
The American Academy of Otolaryngology - Head and Neck Surgery has a revised position statement on surgical management of OSA (AAO-HNS, 2014). 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:
In a position statement, AAO-HNS supported hypoglossal nerve stimulation as an effective second-line treatment of moderate-to-severe OSA in patients who are intolerant or unable to achieve benefit with CPAP (AAO-HNS, 2016). AAO-HNS noted that not all patients are candidates for upper airway stimulation therapy and require a number of assessments to ensure proper patient selection
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Boon et al reported results from 301 patients in the multicenter Adherence and Outcome of Upper Airway Stimulation for OSA International Registry (ADHERE) (Boon, 2018). The ADHERE registry included both retrospective and prospectively collected data from the U.S. and Germany between October 2016 and September 2017. Data were collected from PSG prior to implantation and between 2 and 6 months after implantation, or from home sleep tests which were often performed at 6 and 12 months after implantation as part of routine care. Mean AHI decreased from 35.6 (SD: 15.3) to 10.2 (SD: 12.9) post-titration with 48% of patients achieving an AHI of 5 or less. ESS decreased from 11.9 (5.5) to 7.5 (4.7) (P<.001).
Kent et al pooled data from the ADHERE registry plus data from 3 other studies to evaluate factors predicting success (Kent, 2019). Over 80% of the 584 patients were men, and most were overweight. Seventy seven percent of patients achieved treatment success, defined as a decrease in AHI by at least 50% and below 20 events/per hour. AHI decreased to below 5 in 41.8% of patients. Greater efficacy was observed in patients with a higher preoperative AHI, older patient age, and lower BMI. In a retrospective analysis by Huntley et al of procedures at 2 academic institutions, patients with a body mass index (BMI) of greater than 32 did not have lower success rates than patients with a BMI less than 32 (Huntley, 2018). However, only patients who had palpable cervical landmarks and carried most of their weight in the waist and hips were offered HGNS. Therefore, findings from this study are limited to this select group of patients with BMI greater than 32.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Costantino et al conducted a systematic review and meta-analysis of 6- to 60-month outcomes following HNS (Costantino, 2020). They identified 12 studies with a total of 350 patients with OSA who were treated with the Inspire, ImThera, or Apnex HNS systems. Only the Inspire device has obtained FDA approval as of April 2021 and contributed the largest number of patients to the meta-analysis. In addition to the trials described by Steffen et al and Strollo et al, several other trials with the Inspire system were included in the meta-analysis (Steffen, 2018; Steffen, 2020; Strollo, 2014; Strollo, 2015). At 6 mo follow-up, the overall change in AHI was -17.74 with an improvement in ESS of -5.36. At 12 mo follow-up, the change in AHI was -17.50 with an improvement in ESS of -5.27. Sixty-month data were provided only by the STAR trial as reported by Woodson et al (Woodson, 2018).
Results of prospective single-arm studies show AHI success rates in 66% to 68% of patients who had moderate-to-severe sleep apnea and a favorable pattern of palatal collapse. Mean AHI was 31 to 32 at baseline, decreasing to 14 to 15 at 12 months. ESS scores decreased from 6.5 to 7.0. All improvements were maintained through 5 years of follow-up. Discomfort due to the electrical stimulation and tongue abrasion were initially common but were decreased when stimulation levels were reduced. In the post-market study, a normal ESS score (< 10) was obtained in 73% of patients. A FOSQ score of at least 19 was observed in 59% of patients compared to 13% at baseline. At the 12-month follow-up, 8% of bed partners regularly left the room due to snoring, compared to 75% of bed partners at baseline. The average use was 5.6 + 2.1 h per night. Use was correlated with the subjective outcomes, but not with AHI response. Two- and 3-year follow-up of this study were reported by Steffen et al (2020),, but the percentage of patients at follow-up was only 68% at 2 years and 63% at 3 years, limiting conclusions about the longer-term efficacy of the procedure (Steffen, 2020). A comparison of the populations who had 12-month versus 2- or 3-year results showed several differences between the patients who followed up and those who dropped out, including higher baseline AHI, higher baseline ODI, and trends towards lower usage per night and a lower responder rate at 12 months.
Huntley et al (2021) selected patients in the control group who met criteria for HNS (non-concentric collapse on drug-induced sleep endoscopy and body mass index [BMI] criteria) but had been treated at their institutions by single or multi-level palatal and lingual surgery (Huntley, 2021). There was no explanation of why the different treatments were given during the overlap period of 2010 to 2019, but the HNS patients were older and heavier. HNS resulted in a modestly greater decrease in AHI (HNS: -21.4 vs -15.9. p <.001), but not in ESS (HNS: -4.7 vs -5.8, p =.06). More patients in the HNS group achieved success by the Sher criteria (70% vs 48 to 49%) suggesting that there might be a clinical benefit for some patients.
Another report from ADHERE registry investigators compared outcomes from HNS patients with patients who met criteria but had been denied insurance coverage (Mehra, 2020). In a post-hoc multivariate analysis, previous use of PAP and prior surgical procedures were predictors of insurance approval. In the group of patients who received HNS, the average use downloaded from the device was 5.6 h/night and 92% of patients had usage greater than 20 h/week. A majority of the comparator group (86%) were not using any therapy at follow-up. The remaining 14% were using PAP, an oral appliance, or underwent OSA surgery. The AHI decreased to 15 events/h (moderate OSA) on the night of the sleep test in patients with HNS, with only modest improvement in patients who did not receive HNS. The hours of use on the night of the post-operative sleep study was not reported, and the HNS patients may have been more likely to use their device on the test night. In addition, the use of a home sleep test for follow-up may underestimate the AHI. The ESS improved in the HNS group but worsened in the controls. This suggests the possibility of bias in this subjective measure in patients who were denied coverage.
A report of data from the ADHERE registry by Thaler et al included 640 patients with 6-month follow-up and 382 with 12-month follow-up (Thaler, 2020). AHI was reduced from 35.8 at baseline to 14.2 at 12 months (p <.001), although the number of hours of use during the sleep test was not reported and home sleep studies may underestimate AHI. ESS was reduced from 11.4 at baseline to 7.2 at 12 months (p <.001), and patient satisfaction was high. In a multivariate model, only female sex (odds ratio: 3.634, p =.004) and lower BMI (odds ratio: 0.913, p =.011) were significant predictors of response according to the Sher criteria. In sensitivity analysis, higher baseline AHI was also found to be a negative predictor of success.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Only 1 RCT has been identified on the effect of HNS in patients with OSA. Heiser et al conducted The Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea (EFFECT) trial, a multicenter, randomized, double-blind, crossover design study in adult patients with moderate-to-severe OSA (defined as AHI >15) who were intolerant to CPAP (Heiser, 2021). All individuals included in the study were White. All patients received implantation of HNS device (Inspire Medical Solutions) at least 6 months prior to enrollment. Baseline AHI before implantation was 32.2 events/h; after implantation, baseline AHI was approximately 8.3 events/h. All participants received therapeutic stimulation during the baseline visit. Patients were then randomized to 1 of 2 treatment groups: HNS-Sham (n=45) or Sham-HNS (n=44). After randomization, the HNS-Sham group received therapeutic stimulation and the Sham-HNS received sham stimulation for 1 week. During the second week, the HNS-Sham group received sham stimulation while the Sham-HNS group received therapeutic stimulation. Changes in AHI over time showed a statistically significant decrease in AHI with stimulation compared to sham stimulation during the baseline, week 1, and week 2 visits. This meant that during week 1 when the HNS-Sham group received stimulation, they had significantly lower AHI; during week 2, when the Sham-HNS group received stimulation, they had significantly lower AHI. Similarly, participants reported a lower ESS with stimulation compared to sham stimulation during all visits. The change of AHI and ESS from baseline to the 1-week and 2-week visits was analyzed between the groups and investigators found no evidence of a carryover effect for AHI or ESS.
Yu et al reported on the safety and effectiveness of HNS in 42 adolescents with Down Syndrome and severe OSA (AHI of 10 events/h or greater) (Yu, 2022). This was a single-group, multicenter, cohort study with a 1-year follow-up that included non-obese (BMI <95%) children and adolescents aged 10 to 21 years who were refractory to adenotonsillectomy and unable to tolerate CPAP. Patients who were included had an AHI between 10 and 50 on baseline PSG; the mean baseline AHI was 23.5 (SD, 9.7). All patients included tolerated HNS without any intraoperative complications. The most common complication was tongue or oral discomfort or pain, which occurred in 5 (11.9%) patients and was temporary, lasting weeks or rarely, months. Four patients (9.5%) had device extrusion resulting in readmissions to replace the extruded device. At 12 months, there was a mean decrease in AHI of 12.9 (SD, 13.2) events per hour (95% CI, -17.0 to -8.7 events/h). At the 12-month PSG, 30 of 41 patients (73.2%) had an AHI of less than 10 events/h, 14/41 patients (34.1%) had an AHI of less than 5 events/h, and 3/41 patients (7.3%) had an AHI of less than 2 events/h. There was also a significant improvement in quality of life outcomes. The mean improvement in the OSA-18 total score was 34.8 (SD, 20.3; 95% CI, -42.1 to -27.5) and the ESS improved by 5.1 (SD, 6.9; 95% CI, -7.4 to -2.8).
In 2021, American Academy of Sleep Medicine (AASM) published practice guidelines on when to refer patients for surgical modifications of the upper airway for OSA (Kent, 2021). These guidelines replaced the 2010 practice parameters for surgical modifications (Aurora, 2010). 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 an 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 (Kent, 2021). The systematic review deemed most included data of low quality, consisting of mostly observational data. The AASM strongly recommends that clinicians discuss referral to a sleep surgeon with adults with OSA and body mass index (BMI) <40 kg/m2 who are intolerant or unaccepting of PAP. Clinically meaningful and beneficial differences in nearly all critical outcomes, including a decrease in excessive sleepiness, improved quality of life (QOL), improved Apnea/Hypopnea Index (AHI) or respiratory disturbance index (RDI), and sleep quality, were demonstrated with surgical management in patients who are intolerant or unaccepting of PAP. The AASM makes a conditional recommendation that clinicians discuss referral to a sleep surgeon with adults with OSA, BMI <40 kg/m2, and persistent inadequate PAP adherence due to pressure-related side effects, as available data (very low-quality), suggests that upper airway surgery has a moderate effect in reducing minimum therapeutic PAP level and increasing PAP adherence. In adults with OSA and obesity (class II/III, 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.
In 2012, the American Society for Metabolic and Bariatric Surgery published guidelines on the perioperative management of OSA (ASMBS Clinical Issues Committee, 2012). The guideline indicated that OSA is strongly associated with obesity, with the incidence of OSA in the morbidly obese population reported as between 38% and 88%. The Society recommended bariatric surgery as the initial treatment of choice for OSA in this population, besides CPAP, as opposed to surgical procedures directed at the mandible or tissues of the palate. The updated 2017 guidelines reaffirmed these recommendations (de Raaff, 2017).
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Herman et al published a prospective, open-label, single-arm, nonrandomized trial that investigated multilevel RFA as an alternative therapy for patients with mild-to-moderate OSA (AHI 10 to 30) with intolerance or inadequate adherence to CPAP (Herman, 2023). Patients were treated with 3 sessions of office-based RFA to the soft palate and tongue base. Of the 56 patients recruited for the study, 43 completed the protocol. Overall, 22/43 (51%) were considered complete responders with a ≥50% reduction in baseline AHI and an overall AHI <20 at study completion. A statistically significant reduction in mean and median AHI was observed at 6 months follow‐up (p=.001 for both); the mean AHI decreased from 19.7 to 9.86 and the median AHI decreased from 17.8 to 7.5. Likewise, ODI scores were significantly reduced at 6 months follow‐up; the mean ODI score decreased from 12.79 to 8.36 (p=.006) and the median ODI score decreased from 11.65 to 6.23 (p=.008).
Schwartz et al published results from the ImThera Medical Targeted Hypoglossal Neurostimulation Study #3 (THN3), which investigated the efficacy and safety of targeted HNS of the proximal hypoglossal nerve in patients with moderate-to-severe OSA (AHI 20-60 events per hour) (Schwartz, 2023). This was a multicenter, randomized trial where all patients (N=138) were implanted with the HNS system (aura6000; ImThera Medical), and randomly assigned 2:1 to HNS device activation at 1 or 4 months after implant for the treatment and control groups, respectively. Efficacy was measured at month 4, as well as after 11 months of therapy (study months 12 and 15 for treatment and control groups, respectively). The study included mostly males (86.2%) and White individuals (91.3%). The results demonstrated that at month 4, the treatment group had significantly better outcomes compared to the control group for AHI and ODI scores. However, after 11 months of active therapy, the difference between the treatment and control groups was not statistically significant for AHI (RR, -7.5; 95% CI, -16 to 1.4) but remained significant for ODI (RR, 10.4; 95% CI, 1.6 to 18.8).
Liu et al published a systematic review investigating HNS in adolescents with Down Syndrome and OSA (Liu, 2022). A total of 9 studies were included with a follow up period ranging from 2 to 58 months; 6 studies had sample sizes fewer than 10 patients. In an analysis that included 104 patients, AHI scores were significantly reduced in patients after HNS (mean AHI reduction, 17.43 events/h; 95% CI, 13.98 to 20.88 events/h; p<.001). Similarly, in an analysis that included 88 patients, OSA-18 survey scores were significantly reduced after HNS (mean OSA-18 reduction, 1.67; 95% CI, 1.27 to 2.08; p<.001).
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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