**Notice:**

Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.

**History/Background and/or General Information**

Obstructive sleep apnea (OSA) is a disease characterized by recurrent episodes
of upper airway obstruction during sleep. The disruption in airflow caused by
OSA has been associated with multiple comorbidities, including hypertension,
cardiovascular disease, cardiac arrhythmia, cerebrovascular disease, excessive
daytime sleepiness, and mood disorders. Continuous positive airway pressure
(CPAP) has long been the primary treatment modality of choice for OSA, showing
improvements in many comorbidities. Unfortunately, despite attempts to improve
compliance, many people are unable to tolerate treatment with CPAP. Because of
the large percentage of patients not tolerating CPAP, alternative treatment
strategies are necessary.

The hypoglossal nerve is the twelfth cranial nerve, and innervates all the
extrinsic and intrinsic muscles of the tongue, except for the palatoglossus
which is innervated by the vagus nerve. It is a nerve with a solely motor
function. The nerve arises from the hypoglossal nucleus in the brain stem as a
number of small rootlets, passes through the hypoglossal canal and down
through the neck, and eventually passes up again over the tongue muscles it
supplies into the tongue. There are two hypoglossal nerves in the body: one on
the left, and one on the right.

The concept of stimulating the tongue musculature to increase upper airway
size and limit the pathophysiologic obstruction leading to OSA was introduced
in the late 1980s. A variety of strategies were utilized, including
transcutaneous stimulation with placement of electrodes in the submental
region, sublingual mucosa, and soft palate. However, these studies were
limited by their lack of selective stimulation of the primary protrusor of the
tongue, the genioglossus muscle. In 2001, Schwartz et al performed a trial in
which they selectively stimulated the branches of the hypoglossal nerve,
innervating the genioglossus. They noted a significant improvement in the
apnea-hypopnea index (AHI) and O2 desaturation nadir. This technology was
subsequently refined, and in 2014 the Stimulation Therapy for Apnea Reduction
(STAR) trial was published as the initial clinical trial using upper airway
stimulation (UAS) as an alternative therapy to CPAP for treatment of OSA.

The only Food and Drug Administration (FDA) approved hypoglossal nerve
stimulation (HGNS) system has three implantable components: a stimulation lead
that delivers mild stimulation to maintain multilevel airway patency during
sleep, a breathing sensor lead that senses breathing patterns, and a generator
that monitors breathing patterns. The two external components are a patient
sleep remote that provides a noninvasive means for a patient to activate the
generator and a physician programmer that allows the physician to
noninvasively interrogate and configure the generator settings. The system
battery life for the implantable components is 7 to 10 years.

A surgeon implants the system containing a neurostimulator subcutaneously in
the patient's chest, with one lead attached to the patient's hypoglossal nerve
(cranial nerve XII) at the base of the tongue and one lead implanted in the
patient's chest. The lead in the chest consists of a pressure sensor that
detects breathing. Information about respiration rate is relayed to the
device, which stimulates the hypoglossal nerve in the tongue. When stimulated,
the tongue moves forward, opening the airway. The patient can operate the
device by remote control, which the patient activates before going to sleep.
The device turns on after 20 minutes to minimize disrupting the patient's
sleep onset; the device must be manually turned off via remote when the
patient wakes.

**Covered Indications**

FDA-approved hypoglossal nerve neurostimulation is considered medically
reasonable and necessary for the treatment of moderate to severe obstructive
sleep apnea when **all** of the following criteria are met:

  1. Beneficiary is 22 years of age or older; **and**
  2. Body mass index (BMI) is less than 35 kg/m2; **and**
  3. A polysomnography (PSG) is performed within 24 months of first consultation for HGNS implant; **and**
  4. Beneficiary has predominantly obstructive events (defined as central and mixed apneas less than 25% of the total AHI); **and**
  5. AHI is 15 to 65 events per hour; **and**
  6. Beneficiary has documentation that demonstrates CPAP failure (defined as AHI greater than 15 despite CPAP usage) or CPAP intolerance (defined as less than 4 hours per night, 5 nights per week or the CPAP has been returned) including shared decision making that the patient was intolerant of CPAP despite consultation with a sleep expert; **and**
  7. Absence of complete concentric collapse at the soft palate level as seen on a drug-induced sleep endoscopy (DISE) procedure; **and**
  8. No other anatomical findings that would compromise performance of device (e.g., tonsil size 3 or 4 per standardized tonsillar hypertrophy grading scale).

**Limitations**

The following are not considered reasonable and necessary and therefore will
be denied:

  1. Hypoglossal nerve neurostimulation is considered not medically reasonable and necessary for all other indications.
  2. Non-FDA-approved hypoglossal nerve neurostimulation is considered not medically reasonable and necessary for the treatment of adult obstructive sleep apnea due to insufficient evidence of being safe and effective.
  3. Hypoglossal nerve neurostimulation is considered not medically reasonable and necessary when any of the following contraindications are present:
    * Beneficiaries with central and mixed apneas that make up more than one-quarter of the total AHI.
    * Beneficiaries with an implantable device could experience unintended interaction with the HGNS implant system.
    * BMI equal to or greater than 35
    * Neuromuscular disease
    * Hypoglossal-nerve palsy
    * Severe restrictive or obstructive pulmonary disease
    * Moderate-to-severe pulmonary arterial hypertension
    * Severe valvular heart disease
    * New York Heart Association class III or IV heart failure
    * Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)
    * Persistent uncontrolled hypertension despite medication use
    * An active, serious mental illness that reduces the ability to carry out ADLs and would interfere with the patient's ability to operate the HNS and report problems to the attending provider
    * Coexisting nonrespiratory sleep disorders that would confound functional sleep assessment
    * Beneficiaries who are, or who plan to become pregnant.
    * Beneficiaries who require Magnetic resonance imaging (MRI) with model 3024.
    * Beneficiaries, who require Magnetic resonance imaging (MRI) with model 3028, can undergo MRI on the head and extremities if certain conditions and precautions are met. Please refer to the Manufacturer Guidelines for this model and future models for more information.
    * Beneficiaries who are unable or do not have the necessary assistance to operate the sleep remote.
    * Beneficiaries with any condition or procedure that has compromised neurological control of the upper airway  
  4. Drug Induced Sleep Endoscopy (DISE): 
    * Due to documented inconsistency in determining if complete concentric collapse (CCC) is present, the inserting provider shall be certified by the FDA approved manufacturer's second opinion service of validation via video clip submissions of at least 80% agreement in at least 15 consecutive studies. Inserting providers shall have documentation to submit to this contractor if necessary. 
  5. Shared Decision Making (SDM): 
    * SDM, by definition, is any documented conversation between an attending provider and the patient, and not between multiple providers. Providers shall provide these documents if requested by this contractor.

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.

**Place of Services (POS)**

Hypoglossal nerve stimulation for the treatment of OSA must be furnished in
accordance with the accepted standards of medical practice in a setting
appropriate to the patient's medical needs and condition.

**Provider Qualifications**

Hypoglossal nerve stimulation for the treatment of OSA must be ordered and
furnished by qualified personnel. The hypoglossal nerve (HN) may be damaged
during neck surgeries. A detailed understanding of the anatomy of the
hypoglossal nerve in relation to various anatomical landmarks and surrounding
structures is important to reduce procedural complications and the risk of
nerve damage.

  * Provider Specialties 
    * Insertion of hypoglossal nerve stimulation addressed in this LCD must be performed by a qualified physician (MD or DO) who is a board certified, or a board eligible  **otolaryngologist** having completed a residency and/or fellowship program and maintains ongoing certification in otolaryngology.

Insertion of an FDA-approved hypoglossal nerve stimulation device must be
performed by a qualified physician who completed the appropriate AMA or AOA
certified residency program in otolaryngology. In addition, prior to
implanting the system, surgeons will need to receive classroom instruction by
an FDA approved device manufacturer or equivalent on device implant techniques
as well as cadaver training. Documentation must be provided to support
completion of training to an exemplary level by the manufacturer. Sleep
physicians and sleep technicians shall receive classroom instruction from a
similar facility on how to titrate the device including hands on operation of
the program. Doctors must maintain, for the contractor to review,
documentation of such training completion to a satisfactory level of
completion as established by the device manufacturer or appropriate board
approval of competency. Evaluation, referral and post implant evaluation of
the hypoglossal nerve stimulator, but not including expected post-op care by
the inserting physician, should be performed by board eligible or certified
sleep physician with qualifications as outlined in LCD L33405,
_Polysomnography and Sleep Testing_. In addition, Sleep Technicians shall meet
the same qualifications as outlined in the LCD L33405. Likewise, sleep studies
shall be performed in an accredited sleep facility as stated in LCD L33405.

**Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements in this LCD.

**Published Literature**

**STAR Trial 12 month follow-up:**  
Strollo, et al. for the STAR Trial Group evaluated the clinical safety and
effectiveness of upper-airway stimulation at 12 months for the treatment of
moderate-to-severe obstructive sleep apnea.1 The study included 126
participants; 83% were men. The mean age was 54.5 years, and the mean BMI was
28.4. Exclusion criteria were a BMI of more than 32.0, neuromuscular disease,
hypoglossal-nerve palsy, severe restrictive or obstructive pulmonary disease,
moderate-to-severe pulmonary arterial hypertension, severe valvular heart
disease, New York Heart Association class III or IV heart failure, recent
myocardial infarction or severe cardiac arrhythmias (within the past 6
months), persistent uncontrolled hypertension despite medication use, active
psychiatric disease, and coexisting nonrespiratory sleep disorders that would
confound functional sleep assessment. The study was designed by the sponsor
(Inspire Medical Systems), the investigators, and the FDA as a multicenter,
prospective, single-group trial with participants serving as their own
controls. The primary outcome evaluation was followed by a randomized,
controlled therapy-withdrawal study that included a subgroup of consecutive
participants selected from the population that had a response to therapy. The
primary outcome measures were assessed by means of overnight polysomnography
and scored by an independent core laboratory with the use of standard
criteria. The data analysis was performed by the independent statistician.

Participants underwent screening that included polysomnography, medical and
surgical consultation, and endoscopy during drug-induced sleep. Participants
were excluded if the AHI score from the screening polysomnography was less
than 20 or more than 50 events per hour, if central or mixed sleep-disordered
breathing events accounted for more than 25% of all apnea and hypopnea
episodes, or if the AHI score while the person was not in a supine position
was less than 10 events per hour. Participants were also excluded if
pronounced anatomical abnormalities preventing the effective use or assessment
of upper-airway stimulation were identified during the surgical consultation
(e.g., tonsil size of 3 or 4 [tonsils visible beyond the pillars or extending
to midline]) or if complete concentric collapse at the retropalatal airway was
observed on endoscopy performed during drug-induced sleep. Qualified
participants underwent a surgical procedure to implant the upper-airway
stimulation system (Inspire Medical Systems). The stimulation electrode was
placed on the hypoglossal nerve to recruit tongue-protrusion function; the
sensing lead was placed between the internal and external intercostal muscles
to detect ventilatory effort; the neurostimulator was implanted in the right
ipsilateral mid-infraclavicular region.

The primary outcome was the change in the severity of obstructive sleep apnea
in the study population, as assessed by means of the AHI and the oxygen
desaturation index (ODI; the number of times per hour of sleep that the blood
oxygen level drops by greater than or equal to 4 percentage points from
baseline). The co-primary outcome was the proportion of participants with a
response from baseline to 12 months with respect to the primary outcome
measures of the AHI and ODI scores. A response as measured by means of the AHI
was defined as a reduction of at least 50% from baseline in the AHI score and
an AHI score on the 12-month polysomnography of less than 20 events per hour.
The ODI was chosen as a stable integrative outcome value of all forms of
sleep-disordered breathing. A response as measured by means of the ODI was
defined as a reduction of at least 25% from baseline in the ODI score. The
prespecified primary efficacy objectives were response rates of at least 50%,
as assessed by means of the AHI and ODI. All participants who received an
implant were included in the primary outcome analysis; participants who did
not complete the 12-month visit were considered not to have had a response.

Secondary outcome measures included self-reported sleepiness and disease-
specific quality of life as assessed with the use of the Epworth Sleepiness
Scale (scores range from 0.0 to 24.0, with higher scores indicating more
daytime sleepiness), disease-specific quality of life, as assessed with the
use of the Functional Outcomes of Sleep Questionnaire (FOSQ; scores range from
5.0 to 20.0, with higher scores indicating greater functioning), and the
percentage of sleep time with the oxygen saturation less than 90%.

At the 12-month visit, the first 46 consecutive participants who met the
criterion of having a response to therapy were randomly assigned, in a 1:1
ratio, to the therapy-maintenance group or the therapy-withdrawal group.1 This
design filtered out persons who had not had a response to therapy. The
therapy-withdrawal group had the device turned off for 7 days, whereas the
therapy-maintenance group continued with the device turned on. Polysomnography
was performed after the randomization period to measure the effects of therapy
withdrawal, as compared with continued use of the therapy.

The scores on the AHI and ODI (primary outcome measures) were lower
(indicating fewer episodes of sleep apnea) at 12 months than at baseline. The
median AHI score decreased 68%, from the baseline value of 29.3 events per
hour to 9.0 events per hour. The median ODI score decreased 70%, from 25.4
events per hour to 7.4 events per hour. At the 12-month visit, the criteria
for the coprimary outcome of a reduction of at least 50% in the AHI score from
baseline and an AHI score of less than 20 events per hour were met by 66% of
the participants (83 of 126 participants; lower boundary of the 97.5%
confidence interval [CI], 57). The criterion for the coprimary outcome of a
reduction of at least 25% in the ODI score from baseline was met by 75% of
participants (94 of 126; lower boundary of the 97.5% CI, 66). Both primary
efficacy outcomes exceeded the predefined study objectives.

Scores on the FOSQ and Epworth Sleepiness Scale indicated significant
improvement at 12 months, as compared with baseline. The median percentage of
sleep time with the oxygen saturation less than 90% decreased from a baseline
value of 5.4% to 0.9% at 12 months. The average increase in the AHI score in
the therapy-withdrawal group was 18.2 events per hour, whereas the average
increase in the therapy-maintenance group was 1.7 events per hour (difference
in changes in mean scores, 16.412.0 events per hour; P less than 0.001). A
similar effect was observed with respect to the mean ODI scores.

Two participants had a serious device-related adverse event requiring
repositioning and fixation of the neurostimulator to resolve discomfort. No
permanent tongue weakness was reported during the study. Most of the device-
related events that were not considered to be serious resolved after the
participants acclimated to the upper-airway stimulation therapy or after the
device was reprogrammed to adjust the stimulation variables.

The daily use of upper-airway stimulation was 86%, as assessed on the basis of
self-report. A control group of therapeutic CPAP users (i.e., a comparative-
effectiveness design) would be impractical, given the current study design.

The randomized, controlled therapy-withdrawal study in which some participants
had the therapy turned off for 1 week provided evidence that the therapeutic
effect established at 12 months was attributable to the upper-airway
stimulation therapy, rather than variability in the AHI score.

**STAR Trial 18 month follow-up:**  
Dedhia, et al for the STAR Trial Group evaluated the stability of improvement
in polysomnographic measures of sleep disordered breathing, patient reported
outcomes, the durability of hypoglossal nerve recruitment and safety at 18
months in the Stimulation Treatment for Apnea Reduction (STAR) trial
participants.2 This was a prospective multicenter single group trial with
participants serving as their own controls. Primary outcome measures were the
apnea-hypopnea index (AHI) and the 4% oxygen desaturation index (ODI).
Secondary outcome measures were the Epworth Sleepiness Scale (ESS), the
Functional Outcomes of Sleep Questionnaire (FOSQ), and oxygen saturation
percent time less than 90% during sleep. Stimulation level for each
participant was collected at three predefined thresholds during awake testing.
Procedure- and/or device-related adverse events were reviewed and coded by the
Clinical Events Committee.

The median AHI was reduced by 67.4% from the baseline of 29.3 to 9.7/h at 18
months. The median ODI was reduced by 67.5% from 25.4 to 8.6/h at 18 months.
The FOSQ and ESS improved significantly at 18 months compared to baseline
values. The functional threshold was unchanged from baseline at 18 months. Two
participants experienced a serious device-related adverse event requiring
neurostimulator repositioning and fixation. No tongue weakness reported at 18
months.

The authors concluded that upper airway stimulation via the hypoglossal nerve
maintained a durable effect of improving airway stability during sleep and
improved patient reported outcomes (Epworth Sleepiness Scale and Functional
Outcomes of Sleep Questionnaire) without an increase of the stimulation
thresholds or tongue injury at 18 months of follow-up.

**STAR Trial 24 month follow-up:**  
On behalf of the STAR Trial Investigators evaluated the long-term (24-month)
effect of cranial nerve upper airway stimulation (UAS) therapy on patient-
centered obstructive sleep apnea (OSA) outcome measures.3 This was a
prospective, multicenter, cohort study of 126 patients with moderate to severe
OSA who had difficulty adhering to positive pressure therapy and received the
surgically implanted UAS system. Outcomes were measured at baseline and
postoperatively at 12 months and 24 months, and included self- and bedpartner-
report of snoring intensity, Epworth Sleepiness Scale (ESS), and Functional
Outcomes of Sleep Questionnaire (FOSQ). Additional analysis included FOSQ
subscales, FOSQ-10, and treatment effect size.

Significant improvement in mean FOSQ score was observed from baseline (14.3)
to 12 month (17.3), and the effect was maintained at 24 month (17.2). Similar
improvements and maintenance of effect were seen with all FOSQ subscales and
FOSQ-10. Subjective daytime sleepiness, as measured by mean ESS, improved
significantly from baseline (11.6) to 12 month (7.0) and 24 month (7.1). Self-
reported snoring severity showed increased percentage of "no" or "soft"
snoring from 22% at baseline to 88% at 12 months and 91% at 24 mo. UAS
demonstrated large effect size (greater than 0.8) at 12 and 24 months for
overall ESS and FOSQ measures, and the effect size compared favorably to
previously published effect size with other sleep apnea treatments.

The authors concluded that in a selected group of patients with moderate to
severe OSA and body mass index less than or equal to 32 kg/m2, hypoglossal
cranial nerve stimulation therapy can provide significant improvement in
important sleep related quality-of-life outcome measures and the effect is
maintained across a 2-year follow-up period.

**STAR Trial 36 month follow-up:**  
On behalf of the STAR Trial Investigators describe the 36-month clinical and
polysomnography (PSG) outcomes in an obstructive sleep apnea (OSA) cohort
treated with hypoglossal cranial nerve upper airway stimulation (UAS).4

Of 126 enrolled participants, 116 (92%) completed 36-month follow-up
evaluation per protocol; 98 participants additionally agreed to a voluntary
36-month PSG. Self-report daily device usage was 81%. In the PSG group, 74%
met the a priori definition of success with the primary outcomes of apnea-
hypopnea index, reduced from the median value of 28.2 events per hour at
baseline to 8.7 and 6.2 at 12 and 36 months, respectively. Similarly, self-
reported outcomes improved from baseline to 12 months and were maintained at
36 months. Soft or no snoring reported by bed partner increased from 17% at
baseline to 80% at 36 months. Serious device-related adverse events were rare,
with 1 elective device explantation from 12 to 36 months.

The authors concluded that long-term 3-year improvements in objective
respiratory and subjective quality-of-life outcome measures are maintained.
Adverse events are uncommon. UAS is a successful and appropriate long-term
treatment for individuals with moderate to severe OSA.

**STAR Trial 48 month follow-up:**  
On behalf of the STAR Trial Investigators assess patient-based outcomes of
participants in a large multicenter prospective cohort study-the STAR trial-48
months after implantation with an upper airway stimulation system for moderate
to severe obstructive sleep apnea.5

A total of 91 subjects completed the 48-month visit. Daytime sleepiness as
measured by ESS was significantly reduced (P equal to .01), and sleep-related
quality of life as measured by FOSQ significantly improved (P equal to .01)
when compared with baseline. Soft to no snoring was reported by 85% of bed
partners. Two patients required additional surgery without complication for
lead malfunction.

The authors concluded that upper airway stimulation maintained a sustained
benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in
select patients with moderate to severe obstructive sleep apnea.

**STAR Trial 5 year outcomes:**  
On behalf of the STAR Trial Investigators present 5-year outcomes from a
multicenter prospective cohort of patients with obstructive sleep apnea (OSA)
who were treated with upper airway stimulation (UAS) via a unilateral
hypoglossal nerve implant.6 From a cohort of 126 patients, 97 completed
protocol, and 71 consented to a voluntary polysomnogram. Those having
continuous positive airway pressure failure with moderate to severe OSA, body
mass index less than 32 kg/m2, and no unfavorable collapse on drug-induced
sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes
included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse
events, as well as measures of sleepiness, quality of life, and snoring.

Patients who did and did not complete the protocol differed in baseline AHI,
oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire
scores but not in any other demographics or treatment response measures.
Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was
observed, with normalization of scores increasing from 33% to 78% and 15% to
67%, respectively. AHI response rate (AHI less than 20 events per hour and
greater than 50% reduction) was 75% (n equal to 71). When a last observation
carried forward analysis was applied, the responder rate was 63% at 5 years.
Serious device-related events all related to lead/device adjustments were
reported in 6% of patients.

The authors concluded that there were improvements in sleepiness, quality of
life, and respiratory outcomes are observed with 5 years of UAS. Serious
adverse events are uncommon. UAS is a nonanatomic surgical treatment with
long-term benefit for individuals with moderate to severe OSA who have failed
nasal continuous positive airway pressure.

**Evidence-Based Practice Guidelines and Position Statements**

**American Academy of Sleep Medicine**  
The American Academy of Sleep Medicine (AASM) Clinical Practice Guideline for
Diagnostic Testing for Adult OSA states that the third edition of the
International Classification of Sleep Disorders (ICSD-3) defines OSA as a PSG-
determined obstructive respiratory disturbance index (RDI) greater than or
equal to 5 events/hour associated with the typical symptoms of OSA (e.g.,
unrefreshing sleep, daytime sleepiness, fatigue or insomnia, awakening with a
gasping or choking sensation, loud snoring, or witnessed apneas), or an
obstructive RDI greater than or equal to 15 events/hour (even in the absence
of symptoms).

**American Academy of Otolaryngology Head and Neck Surgery (AAO-HNS)**  
In 2016, the American Academy of Otolaryngology Head and Neck Surgery issued a
position statement on hypoglossal nerve stimulation for treatment of
obstructive sleep apnea (OSA) which states "The American Academy of
Otolaryngology Head and Neck Surgery considers upper airway stimulation (UAS)
via the hypoglossal nerve for the treatment of adult obstructive sleep apnea
syndrome to be an effective second-line treatment of moderate to severe
obstructive sleep apnea in patient who are intolerant or unable to achieve
benefit with positive pressure therapy (PAP). Not all adult patients are
candidates for UAS therapy and appropriate polysomnographic, age, BMI and
objective upper airway evaluation measures are required for proper patient
selection."

**International Society for Sleep Surgery**  
International Society for Sleep Surgery states that Cranial nerve (hypoglossal
nerve) stimulation is among surgical treatments and procedures that "have been
shown to be effective in the treatment of sleep disordered
breathing/obstructive sleep apnea syndrome in adults (and/or children) when
applied to selected patients based on their anatomy, physiology, body mass
index and neck size, prior therapy and co-morbidities. Patient should have
undergone an appropriate evaluation(s) prior to treatment which may include
polysomnography, home sleep testing, awake or drug induced sleep endoscopy,
and possible cephalometric or other radiographic evaluations."

**National Institute for Health and Clinical Excellence (NICE)**  
In 2017, National Institute for Health and Clinical Excellence (NICE) issued
an interventional procedure guidance (IPG598) which states: "Current evidence
on the safety and efficacy of hypoglossal nerve stimulation for moderate to
severe obstructive sleep apnea is limited in quantity and quality. Therefore,
this procedure should only be used with special arrangements for clinical
governance, consent and audit for research."

**CAC Advisory Committee (CAC) Evidentiary Summary  **

After review of the literature, the consensus among the CAC Advisory Committee
(CAC) panel was positive for hypoglossal nerve stimulation (HNS) as a viable
treatment option for patients with moderate to severe Obstructive Sleep Apnea
(OSA). Upper airway stimulation (UAS) compared favorably with sleep surgeries
(e.g., uvulopalatopharyngoplasty (UPPP), trans-oral robotic surgery (TORS)
used to treat tongue base obstruction. CAC discussions regarding patient
criteria included changing the body mass index (BMI) to <35 based on
additional studies that included the higher BMI with successful results, and
including expanded descriptions of limitations to clarify the rationale for
limiting certain patients from this procedure. Also, based on the CAC panel
discussion and the Food and Drug Administration (FDA), it was suggested that
the apnea-hypopnea index (AHI) should start at 15 with the upper limit of the
AHI being increased to 65. This limit was adopted and the Covered Indications
now include patients that have an AHI of 15 to 65 events per hour. In
addition, CAC members agree that providers who underwent FDA approved device
manufacturer DISE training prior to the date of this LCD, shall be deemed to
meet the criteria for satisfactory performance of DISE without further
documentation. All such providers shall maintain certification of completion
of this training, supply proof of training by manufacturer and DISE results
should be made available upon request. Finally, not all adults are candidates
for UAS therapy and appropriate polysomnographic, age, BMI and objective upper
airway evaluation measures are required for proper patient selection. Overall,
this is an appropriate method of treating OSA for the Medicare population.

The evidence on hypoglossal nerve stimulation for the treatment of obstructive
sleep apnea (OSA) includes case series and a multicenter, prospective, single
group, cohort design study (STAR) that were surgically implanted with an upper
airway stimulation device with obstructive sleep apnea who had difficulty
either accepting or adhering to CPAP therapy and were followed for 5 years.
Prospective cohort study is gold standard for epidemiologic studies. The study
strengths included measuring primary and secondary outcomes and at 12-month
visits, a second randomized study within the study where participants were
randomly assigned into two groups with one group having the device turned off
for 7 days and the other continued with the device turned on. Polysomnography
was performed after the randomization period to measure the effects of therapy
withdrawal as compared to continued use of the therapy.1

Hypoglossal nerve stimulation has shown improved outcomes in this single arm
study when used in a select group of patients. For the patients that met the
inclusion criteria for AHI, BMI and favorable pattern for palatal collapse
about two-thirds met the study definition of success. Results observed at the
12 month follow-up were maintained at 3 years. Patient based outcomes at 48
months, concluded these patients maintained a sustained benefit on patient
reported outcomes (Epworth Sleepiness Score, Functional Outcomes of Sleep
Questionnaire and snoring). Conclusions from the 5 year outcomes were that UAS
is a nonanatomic surgical treatment with long-term benefit for individuals
with moderate to severe OSA who have failed nasal continuous positive airway
pressure. Safety and effectiveness were evaluated using multiple outcome
measures.

For individuals with obstructive sleep apnea who are treated with hypoglossal
nerve stimulation, the evidence is sufficient to determine that the technology
results in a meaningful improvement in the net health outcome when utilized as
outlined in this LCD.