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«Oxford UnitedHealthcare® Oxford Clinical Policy OBSTRUCTIVE SLEEP APNEA TREATMENT Policy Number: OUTPATIENT 020.32 T2 Effective Date: October 1, ...»

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Oxford

UnitedHealthcare® Oxford

Clinical Policy

OBSTRUCTIVE SLEEP APNEA TREATMENT

Policy Number: OUTPATIENT 020.32 T2 Effective Date: October 1, 2016

Table of Contents Page Related Policies

INSTRUCTIONS FOR USE

CONDITIONS OF COVERAGE

BENEFIT CONSIDERATIONS

COVERAGE RATIONALE

DEFINITIONS

APPLICABLE CODES

 Orthognathic (Jaw) Surgery DESCRIPTION OF SERVICES

CLINICAL EVIDENCE

U.S. FOOD AND DRUG ADMINISTRATION

REFERENCES

POLICY HISTORY/REVISION INFORMATION................ 25

INSTRUCTIONS FOR USE

This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies.

When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan upon which this Clinical Policy is based. In the event of a conflict, the member specific benefit plan document supersedes this Clinical Policy. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Clinical Policy. Other Policies may apply.

UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intendedto be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.

CONDITIONS OF COVERAGE

–  –  –

Before using this policy, please check the member specific benefit plan document and any federal or state mandates, if applicable.

Essential Health Benefits for Individual and Small Group For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit plan document to determine benefit coverage.

COVERAGE RATIONALE

Nonsurgical Treatment Removable oral appliances are proven and medically necessary for treating obstructive sleep apnea (OSA) as documented by polysomnography.

Refer to the policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Oral Appliances (Mandibular Advancement Devices), A-0341 (ACG).

Removable oral appliances are unproven and not medically necessary for treating central sleep apnea.

This type of sleep apnea is caused by impaired neurological function, and these devices are designed to manage physical obstructions.

Nasal dilator devices are unproven and not medically necessary for treating obstructive sleep apnea (OSA).

There is insufficient clinical evidence supporting the safety and efficacy of nasal dilators for treating OSA. Results from available studies indicate that therapeutic response is variable among the participants. Further research from larger, well-designed studies is needed to evaluate the effectiveness of the device compared with established treatments for OSA, to determine its long-term effectiveness and to determine which patients would benefit from this therapy.

Surgical Treatment The following surgical procedures are proven and medically necessary for treating obstructive sleep apnea as documented by polysomnography.

Refer to the policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. Also see the Definitions section below for information on the definitions and severity of OSA.

 Uvulopalatopharyngoplasty (UPPP): For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Uvulopalatopharyngoplasty (UPPP), A-0245 (AC).

 Maxillomandibular Advancement Surgery (MMA): For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Maxillomandibular Osteotomy and Advancement, AACG). Also see the policy titled Orthognathic (Jaw) Surgery.





 Multilevel Procedures Whether Done in a Single Surgery or Phased Multiple Surgeries: There are a variety of procedure combinations, including mandibular osteotomy and genioglossal advancement with hyoid myotomy (GAHM). For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Mandibular Osteotomy, A-0247 (ACG).

The following surgical procedures are unproven and not medically necessary for treating obstructive sleep

apnea:

 Laser-assisted uvulopalatoplasty (LAUP)  Palatal implants  Lingual suspension - also referred to as tongue stabilization, tongue stitch or tongue fixation  Transoral robotic surgery (TORS)  Implantable hypoglossal nerve stimulation  Radiofrequency ablation of the soft palate and/or tongue base There is insufficient evidence to conclude that laser-assisted uvulopalatoplasty (LAUP) results in improved apneahypopnea index (AHI) or secondary outcomes. Some studies saw a worsening of symptoms as well as increased complications.

–  –  –

There is insufficient evidence to support the safety, efficacy and long-term outcomes of lingual suspension in the treatment of OSA. The published peer-reviewed medical literature includes a few small, uncontrolled studies with short-term follow-up. Large, controlled studies, with long-term follow-up, comparing lingual suspension to established procedures are necessary.

There is insufficient evidence to support the safety, efficacy and long-term outcomes of transoral robotic surgery (TORS) in the treatment of OSA. Large, controlled studies, with long-term follow-up, comparing TORS to established procedures are necessary.

There is insufficient evidence to support the safety, efficacy and long-term outcomes of hypoglossal nerve stimulation in the treatment of OSA. The optimal patient selection criteria for the use of hypoglossal nerve stimulation have not been defined. Randomized controlled trials or comparative effectiveness trials with long-term follow-up, comparing hypoglossal nerve stimulation to established procedures are necessary to evaluate the effectiveness of this technology.

There is insufficient evidence to support the efficacy and long-term outcomes of radiofrequency ablation of the tongue or soft palate in the treatment of OSA. Optimal patient selection criteria have not been defined. Large controlled studies or comparative effectiveness trials with long-term follow-up comparing radiofrequency ablation to established procedures are necessary.

Follow-up polysomnography should be performed following surgery to evaluate response to treatment (Kushida et al., 2006; Ferguson et al., 2006). Refer to the policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information.

DEFINITIONS

According to the American Academy of Sleep Medicine (AASM) the diagnosis of OSA is confirmed if the number of obstructive events† (apneas, hypopneas + respiratory event related arousals) on polysomnography (PSG) is greater than 15 events/hour or greater than 5/hour in a patient who reports any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping or choking; or the bed partner describing loud snoring, breathing interruptions or both during the patient’s sleep (Epstein et al., 2009).

† The frequency of obstructive events is reported as an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI). RDI has at times been used synonymously with AHI, but at other times has included the total of apneas, hypopneas and respiratory effort related arousals (RERAs) per hour of sleep. When a portable monitor is used that does not measure sleep, the RDI refers to the number of apneas plus hypopneas per hour of recording.

OSA severity is defined as:

 Mild for AHI or RDI ≥ 5 and 15  Moderate for AHI or RDI ≥ 15 and ≤ 30  Severe for AHI or RDI 30/hr

APPLICABLE CODES

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or noncovered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies may apply.

–  –  –

DESCRIPTION OF SERVICES

Obstructive sleep apnea (OSA) is a breathing disorder that is defined by either a decrease or complete cessation of airflow during sleep. In OSA, airflow is obstructed when the muscles in the back of the throat fail to keep the airway open. Nocturnal respiration in patients with OSA is characterized by apnea (breathing cessation) and hypopnea (marked reduction in breathing volume). The signs and symptoms of untreated OSA include excessive daytime sleepiness, loud snoring, nocturnal choking, apneas or choking witnessed by bed partner, unrefreshing sleep, morning headaches, reduced libido and enuresis. Physiological effects of untreated OSA include fluctuating blood oxygen levels, increased heart rate, chronic daytime hypertension and impaired glucose tolerance/insulin resistance.

OSA can occur at one or more "levels" of the nasopharyngo-tracheal airway. Type I disease involves narrowing or collapse of the retropalatal region. Type III disease involves collapse in the retrolingual area (tongue base). Type II disease involves narrowing or collapse of both the retropalatal and retrolingual areas. Major OSA is usually a multilevel disorder, with tissues of the soft palate, lateral pharyngeal walls and tongue base all contributing to airway impingement. Intra-nasal tissue, adenoids and tonsils may also play a role (AASM, 2008).

Diagnosis and evaluation of sleep apnea syndrome is determined through polysomnography (PSG) or limited channel testing. Treatment for OSA includes lifestyle modifications (weight loss, avoidance of alcohol or other agents that decrease upper airway patency), positional therapy, positive airway pressure, oral appliance therapy and surgery.

Positive airway pressure therapy may use any one of the following techniques: continuous positive airway pressure (CPAP), automatic positive airway pressure (APAP), bilevel positive airway pressure (BiPAP), variable positive airway pressure (VPAP).

–  –  –

Oral appliances are recommended for treating OSA in ANY of the following circumstances:

 Mild OSA AND patient is unable to tolerate positive airway pressure (PAP) therapy OR refuses PAP  Moderate to severe OSA as a component of treatment that includes additional modalities such as PAP therapy with reduced pressure  As a standalone treatment for moderate to severe OSA, if patient is unable to tolerate PAP therapy OR refuses PAP, although this may not be the most effective therapy A nasal dilator is a removable appliance that is placed just inside the nostril and is secured in place with hypoallergenic adhesive. Using small valves, the device increases pressure inside the nose by creating resistance during exhalation to maintain an open airway during sleep (Theravent website).

There are a variety of surgical options used to treat OSA. The intention of surgery is to create a more open airway so obstructions are less likely to occur.

Implantable hypoglossal nerve stimulation systems are being evaluated as a way to relieve upper airway obstruction.

There are two hypoglossal nerve stimulation systems that are being evaluated: the Inspire® Upper Airway Stimulation device (Inspire Medical) and the aura6000™ Sleep Therapy System (ImThera Medical). A third device, the HGNS System (Apnex Medical), has been discontinued and the manufacturer is no longer in business. The Inspire device is intended to treat moderate-to-severe obstructive sleep apnea (OSA) and is designed for use in patients who are unable or unwilling to use a CPAP device. Inspire’s construction and implantation are comparable to those of a pacemaker: a surgeon implants the device 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, thus 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 turns off via remote when the patient wakes.



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