Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    The diagnosis and treatment of moderate or severe obstructive sleep apnea (OSA) is covered when medically necessary.

2)    Surgical treatment of OSA requires pre-authorization.

3)    Use of an implantable Neurostimulator device such as the Inspire Upper Airway Stimulator requires pre-authorization.

4)    Treatment of OSA with Provigil (Modafinil) or Nuvigil (Armodafinil) requires pre-authorization (see BI170). 

5)    Treatment of OSA with other medications is not covered.

6)    The treatment of OSA with Continuous Positive Airway Pressure (CPAP) or oral appliances is covered when medically necessary and does not require prior authorization.

7)    Repeat sleep study is not required for replacement of CPAP or oral appliance.

8)    OSA may be diagnosed, in patients with a high pre-test likelihood of OSA, by stand-alone/ambulatory home sleep test (HST) that records at least three channels, including pulse oximetry. Initial stand-alone/ambulatory HST does not require preauthorization but we encourage the use of preferred vendors. QualChoice identifies preferred vendors on the basis of quality, convenience and cost-effectiveness. Depending on the specific plan and benefit structure, the use of preferred vendors may result in reduced member costs. If patients have significant illness such as chronic obstructive pulmonary disease, congestive heart failure, seizure disorder, neuromuscular disease, or specific factors complicating sleep then OSA may be diagnosed (with treatment titration, if needed, the same night) in a sleep laboratory. As with HST, the use of preferred sleep laboratory vendors may result in significant savings for members.

9)    Polysomnography performed in a sleep laboratory will require preauthorization to verify there are significant comorbidities or specific complicating factors. Sleep studies performed more than twice in a calendar year (by HST or in a sleep lab) will require pre-authorization.

1)    Diagnosis

A.   Use of a home sleep testing device that monitors at least three channels is considered medically necessary for the diagnosis of OSA:

i)     In members with a high probability of OSA who do not have significant comorbidities such as chronic obstructive pulmonary disease, congestive heart failure, seizures or neuromuscular disease.

ii)    Requires interpretation by a sleep specialist.

iii)   Stand-alone/ambulatory HST less than three times per year does not require preauthorization but we encourage the use of preferred vendors. QualChoice identifies preferred vendors on the basis of quality, convenience and cost-effectiveness. Depending on the specific plan and benefit structure, the use of preferred vendors may result in reduced member costs. Stand-alone/ambulatory home sleep testing is generally performed on a single occasion to confirm a clinical impression of OSA. Repeat testing is generally only required if there is a substantial change, such as major weight loss. In any case, home sleep testing will not be covered more than twice per year without preauthorization.

B.   Diagnosis of OSA by sleep study or polysomnography in a sleep lab (including performance of a split night study for titration of CPAP) requires preauthorization.  As with HST, the use of preferred sleep laboratory vendors may result in significant savings for members. Sleep lab testing is considered medically necessary for any of the following:

i)     BMI:

a)    BMI >40, OR

b)    Pulmonary function studies show obesity hypoventilation syndrome, OR

c)    BMI >35 plus arterial blood gas with PCO2 >45, OR

d)    BMI>35 plus inability to lie flat in bed, OR

ii)    Significant comorbidities such as:
a)  Moderate to severe pulmonary disease for example asthma or COPD, OR    

b)    Moderate to severe CHF with documented pulmonary congestion or known left ventricular ejection fraction of <45%, OR

c)    Uncontrolled seizures, OR

d)    Neuromuscular disease, OR

e)    Factors complicating sleep such as narcolepsy, central sleep apnea, periodic limb movement disorder or parasomnias,

C.   Polysomnography can usually diagnose OSA and titrate CPAP within a single night (CPT code 95811 “split night” PSG & titration). If a member meets criteria for sleep lab testing, 95810 OR 95811 will be approved. However, if OSA is not documented, CPAP titration is not needed and 95810 should be billed. Occasionally it may be necessary to do titration on a subsequent night, such as if the patient does not fall asleep early enough to obtain adequate diagnostic information. In these situations, the first night should be billed as 95810 and a separate request will need to be submitted (if clinically indicated) for titration. The separate request should provide the full results of the initial 95810 study, a copy of the split night protocol and the specific reasons a split night study could not have been performed initially.  As with home sleep testing, it may be necessary to repeat polysomnography after a substantial change, such as surgical treatment.

If polysomnography (95810 or 95811) is requested based on a home sleep test, the complete results of the home sleep test (not just an interpretation) need to be provided.

D.  Multiple sleep latency or maintenance of wakefulness testing:

i)   Is not considered medically necessary for the diagnosis or treatment of OSA. 

ii)  Is considered medically necessary for the diagnosis or monitoring of other sleep disorders, such as narcolepsy.

2)    Non-Surgical Treatment

CPAP

A.   A CPAP is considered medically necessary DME for members with a positive facility-based or home sleep test when: 

i)   The sleep study is based on a minimum of 2 hours of continuous recorded sleep, OR

ii)  Shorter periods of continuous recorded sleep if the total number of recorded events during that shorter period is at least the number of events that would have been required in a 2 hour period, AND

iii)   Positivity is defined by the following criteria:

(a)  Strongly positive with member`s Apnea Hypopnea Index (AHI) ≥30 events per hour with a minimum of 60 events

(b)  Moderately positive with member’s AHI ≥ 15 events per hour with a minimum of 30 events; OR 

(c)  Mildly positive with member’s AHI >5 and <15 events per hour with a minimum of 10 events AND at least one of the following is met:

§  Documented history of stroke; OR

§  Documented hypertension (systolic blood pressure >140 mm Hg and/or diastolic blood pressure >90 mm Hg); OR

§  Documented ischemic heart disease; OR

§  Documented symptoms of impaired cognition, mood disorders, or insomnia; OR

§  Excessive daytime sleepiness (documented by Epworth Sleepiness Scale >10); OR

§  >20 episodes of oxygen desaturation (oxygen saturation of <85%) during a full night sleep study, or any one episode of severe oxygen desaturation (oxygen saturation of <70%).  

B.   For patients without significant comorbidities, an auto-titrating CPAP device does not require prior authorization and can be prescribed for home use. CPAP accessories and supplies required for maintaining use of the machine are covered for members who meet criteria for positive airway pressure devices.

ORAL APPLIANCES

A.   Custom-fitted and prefabricated oral appliances to reduce upper airway collapsibility are considered medically necessary for members with OSA who meet the above medical necessity criteria for CPAP and:

i)   A trial with CPAP has failed or is contraindicated, AND

ii)  The device is prescribed by a treating physician, AND

iii)   The device is custom-fitted by qualified dental personnel, AND

iv)   There is absence of temporomandibular dysfunction or periodontal disease.

3)    Surgical Treatment

Surgical Treatment for OSA requires pre-authorization for the following:

a)    Uvulopalatopharyngoplasty (UPPP) – Uvulopalatopharyngoplasty is used to treat OSA by enlarging the oropharynx. It is considered medically necessary for OSA members who:

i)   Meet the criteria for CPAP, AND

ii)  Have failed or who are intolerant to CPAP***.

b)    Jaw Realignment Surgery (i.e., hyoid Myotomy and suspension, mandibular osteotomy, genioglossal advancement) – Jaw realignment surgery is considered medically necessary for persons who fail other treatment approaches for OSA.

i)   Note: According to the medical literature, persons undergoing jaw realignment surgery must usually also undergo orthodontic therapy to correct changes in occlusion associated with the surgery. Orthodontic therapy (i.e., the placement of orthodontic brackets and wires) is excluded from coverage under standard QualChoice medical plans regardless of medical necessity. Please check benefit plan descriptions for details. Benefits for orthodontic therapy may be available under the member`s dental plan, if any.

c)    Tracheostomy – Tracheostomy is considered medically necessary for those members with the most severe obstructive sleep apnea not manageable by other interventions. Requests for tracheostomy for OSA are subject to medical review.

d)    Use of an implantable Neurostimulator (0424T – 0436T, 0466T, 0467T, 0468T, 61886, 61888, 95970, 95971, 95974 and 95975) is considered medically necessary for members who:

i)   Have failed or are intolerant to CPAP***, AND

ii)  Are 22 years of age or older, AND

iii) Have a BMI of ≤ 32 kg/m2, AND

iv) Have moderate to severe OSA with an AHI of 20 – 50 on PSG (with < 25% central or mixed apneas), AND

v)  Are free of complete concentric collapse of the velopharynx with drug-induced, sedated endoscopy, AND

vi) ENT examination shows no anatomic abnormalities (ie. tonsillar hypertrophy) that might prevent effective use of the device, AND

vii)    Have no history of any condition or procedure that has compromised neurologic control of the upper airway, AND

viii)  Are able to operate the sleep remote, AND

ix) Have no implantable device susceptible to unintended interaction with the Inspire system, AND

x)  Are not pregnant or planning to become pregnant, AND

xi) The surgeon performing the neurostimulator implantation has documentation of training/certification to perform the procedure, AND

xii)    An informed consent form has been discussed with the member and signed to acknowledge an understanding of the potential complications.  There can also be complications associated with removal of the neurostimulator (if not working/tolerated).

e)    All other treatments for OSA are considered experimental and investigational.

*** Failure or intolerance to CPAP is highly subjective and for that reason it needs to be clearly defined.  CPAP intolerance is very common and often takes several months of working with a sleep specialist to make adjustments and try different settings, different face masks, nasal pillows, CPAP, biPAP, autoPAP, etc.  Unwillingness to try PAP for at least 6 months does not meet the criteria of intolerance.  There needs to be true intolerance of non-invasive measures before invasive surgical measures (and associated potential complications) are considered. 

If after 6 months of PAP use (with appropriate adjustments as noted above), a member is unable to, on average, use PAP for at least 4 hours per night and 5 nights per week, this would meet the criteria for true intolerance.

If after 6 months of PAP use, the AHI remains ≥ 15 events per hour with a minimum of 30 events per night, this would meet the criteria for failure.

Codes Used In This BI:

1)    The treatment of snoring alone is not considered medically necessary and is not covered.

2)    Diagnosis

a)    Sleep testing will not be covered on consecutive nights.

b)    Normally (per CMS guidelines), 95811 (split night PSG study followed by CPAP titration) can be performed in one night.  If 95811 titration cannot be completed in one night, it should be billed as 95810.  A separate request/approval would then be needed (with positive results from 95810 provided) for completion of CPAP titration (95811) and that would need to be scheduled for a subsequent night.   Requests for simultaneous approval of both 95810 AND 95811 will not be approved since most of the time this will be redundant and not medically necessary.  If 95810 and 95811 are performed on the same or consecutive nights, only 95811 will be allowed.

c)    Sleep testing will not be covered more often than twice in 12 months.

d)    HST not performed by a Joint Commission accredited ambulatory Independent Diagnostic Testing Facility (IDTF) will not be covered.

e)    Actigraphy alone for the diagnosis of OSA is considered experimental and investigational and is not covered.

f)     Respiratory Disturbance Index (RDI) adds other (non-obstructive, “respiratory effort related arousal”) causes of sleep disruption to the AHI.  Because of this, RDI cannot be used instead of AHI to diagnose OSA and need for treatment.

g)     The use of home sleep testing devices that monitor fewer than three channels or that relies on recording of snoring is considered experimental and investigational and is not covered.

h)    Other techniques for diagnosis of OSA, including but not limited to sonography, static charge sensitive beds, cephalography, and laryngeal function studies, are considered experimental and investigational.

3)    Treatment

a)    DME payment may be subject to plan limitations.

b)    Laser-assisted uvulopalatoplasty (LAUPP) is considered experimental and investigational for treatment of OSA.

c)    CPAP is not considered medically necessary for the treatment of upper airway resistance syndrome (UARS). 

d)    Oral appliances to reduce upper airway collapsibility are considered experimental and investigational for indications other than OSA. 

e)    QualChoice considers UPPP experimental and investigational for persons who do not respond to CPAP because this surgical approach has not been shown to be effective in non-obstructive apnea.

Obstructive sleep apnea (OSA) is a syndrome characterized by repetitive upper airway closure during sleep resulting in repeated reversible blood oxygen desaturation and fragmented sleep.  Besides causing excessive daytime sleepiness and fatigue, OSA has been associated with a range of pathophysiological changes that im­pair cardiovascular function, including increased blood inflam­matory markers and repeated rises in blood pressure during sleep. There is increasing evidence that OSA promotes the develop­ment of hypertension, stroke, myocardial infarction, and prema­ture death.  Community based studies suggest that moderate to severe OSA increases the risk of all-cause mortality (hazard ratios 3.0-6.24), largely but not entirely because of increased cardiovascular risk.  This mortality risk is at least partially offset by treatment with CPAP.  Because obesity is a major risk factor for OSA, the prevalence of OSA is increasing in the United States.  Current estimates are that 2-4% of the adult population suffers from OSA.  Certain populations have much higher prevalence; approximately 30% of commercial truckers have at least moderate OSA.

Data from the history and physical examination have been shown to be sensitive but not specific for diagnosing OSA.  The following signs and symptoms may suggest significant risk for OSA: reported apneas by sleep partner; awakening with choking; intense snoring; severe daytime sleepiness, especially with impairment of driving; obesity (body mass index [BMI] greater than or equal to 30); large neck circumference; and hypertension.

Diagnostic tests for OSA can be classified into 4 types.  The most comprehensive type is Type I: attended, or in-facility polysomnography (PSG), also called nocturnal polysomnography (NPSG). There are 3 categories of portable monitors (used in both attended and unattended settings).  Type II monitors have a minimum of 7 channels (e.g., electroencephalogram (EEG), electrooculogram (EOG), electromyogram (EMG), electrocardiogram (ECG), heart rate, airflow, respiratory effort, oxygen saturation). Type III monitors has a minimum of 4 monitored channels including ventilation or airflow (at least 2 channels of respiratory movement or respiratory movement and airflow), heart rate or ECG, and oxygen saturation. Type IV is all other monitors that fail to fulfill criteria for type III monitors. Type IV monitors are split into two subgroups: those assessing three or more bio parameters including pulse oximetry (IV(A)--most newer monitors fall here) and those assessing one or two bio parameters (the original ASDA level IV category, now called IV(B)). NPSG is considered the definitive test for OSA and other sleep disorders. Type II, III, and IV(A) monitors have been used in the home (unattended) setting, and show adequate sensitivity and specificity for diagnosing OSA in that setting when used for patients with high pre-test probability. The sensitivity and specificity of IV (B) monitors in the home are less robust. Home sleep testing is not appropriate for diagnosis of sleep disorders other than OSA. It is expected that members receive lifestyle advice where applicable (i.e., helping people to lose weight, stop smoking and/or decrease alcohol consumption), as these interventions may be adequate to resolve symptoms.

Patients with OSA suffer from numerous apneic events while sleeping, due to collapse of the upper airway during inspiration. Continuous positive airway pressure, and more recently, BiPAP, DPAP, VPAP, and AutoPAP, have been used in the treatment of OSA as a means of serving as a "pneumatic splint" in order to prop open the airways during inspiration. Use of CPAP may require titration in a sleep lab. This titration can be accomplished in a separate overnight session, or, as a more economical and convenient method, in a split-night study on the same night that the diagnosis of OSA is confirmed. Alternatively, for patients with OSA and without other sleep disorders, self-titrating CPAP (AutoPAP) can be prescribed and is usually well tolerated. Long term adherence to CPAP therapy was initially reported to range from 65-80% (Nino-Murcia, et al., 1989; Waldhorn, et al., 1990; Rolfe, et al., 1991; Hoffstein, et al., 1992) with 8-15% of patients refusing to accept treatment (Waldhorn, 1990; Krieger, 1992) after a single night`s use. More recent studies have shown up to 80% of patients falling into the category of regular users (Pepin, et al., 1999).

A variety of oral appliances and prostheses, including tongue retainers and mandibular advancing devices, have been used to treat patients with OSA. These devices modify the airway by changing the posture of the mandible and tongue. A task force of the Standards of Practice Committee of the ASDA concluded that, despite the considerable variation in the design of these devices, their clinical effects in improving OSA have been consistent (Kushida, et al., 2006). These devices have been shown to be effective in alleviating OSA, and present a useful alternative to CPAP or surgery (Ferguson, et al. 2006; Gotsopoulos, et al., 2002). Oral appliances, however, have been shown to be less reliable and effective than CPAP, and therefore the literature suggests that their use should generally be reserved for patients who are intolerant of CPAP. Oral appliances can be prefabricated or custom fabricated. There is evidence of the efficacy of both prefabricated and custom-fabricated appliances for obstructive sleep apnea (Vanderveken, et al., 2008; Henke, et al., 2000).

While virtually all studies report that surgical treatment of OSA improves snoring and daytime sleepiness, improvements in objective outcomes have been inconsistent, and some patients will continue to require CPAP even after surgical treatment. Fujita is credited with developing the UPPP as a method of enlarging the oropharynx (Fujita, et al., 1985). He based the UPPP on his observation that patients with OSA, without other obvious sites of obstruction, often have a large edematous uvula, wide posterior tonsillar pillar mucosa, and redundant mucosal folds in the lateral posterior pharyngeal walls extending from the nasopharynx to the hypopharynx. The surgery attempts to remove the redundant tissue but preserve the underlying muscular layer. In brief, the mucosa and submucosa of the soft palate, tonsillar fossa and the lateral aspect of the uvula are resected. The posterior pillar may be resected if contributing to the narrowing. In essence the amount of tissue removed is individualized for each patient, determined by the potential space and the width of the tonsillar pillar mucosa between the two palatal arches (Fujita, et al., 1985). The UPPP enlarges the oropharynx but cannot correct obstructions in the hypopharynx. Early on it was recognized that UPPP failed in about 50% of unselected patients with OSA. Uvulopalatopharyngoplasty has been found to be most reliably effective in OSA patients who have adequately responded to a trial of CPAP. If CPAP is unsuccessful in relieving a patient’s symptoms, this suggests that apnea is not due to obstruction. Riley, et al. (1990) proposed that these failures may have been caused by an obstruction at the base of the tongue. The surgical approach to this problem has been to either modify the tongue itself or reposition the tongue by repositioning the mandible and/or maxilla. 

A small randomized controlled trial (n=45) with 8 months of follow-up evaluated laser-assisted uvulopalatoplasty (LAUPP) versus no treatment for mild OSA. Although patients who underwent an average of 2.4 LAUPP procedures had statistically significant improvements in snoring and apnea-hypopnea index relative to the control group, improvements in daytime sleepiness and sleep apnea quality of life (QOL) scores were not statistically significant. Moreover, the benefits of LAUPP were limited, corresponding to a 44% decrease in mean snoring intensity and 35% decrease in apnea-hypopnea index. Another randomized trial of LAUPP involved a randomized crossover design in which patients were randomly assigned to LAUPP or radiofrequency ablation (RFA) of the palate and then allowed to undergo the non-assigned treatment if their assigned treatment did not provide adequate improvement. Although this study was small (n=17) and involved only 16 weeks of follow-up, the results suggest that multiple LAUPP and RFA treatments of the palate reduce snoring but do not significantly reduce the other symptoms of sleep-disordered breathing such as daytime sleepiness or upper airway collapse. There has been little peer-reviewed study of laser-assisted uvulopalatopharyngoplasty (LAUPPP) for the treatment of OSA.

Tracheostomy, which simply bypasses the obstructing lesion of the upper airways, has been shown to be the most effective and predictable surgical approach to OSA. However, the social and medical morbidities of a permanent tracheostomy and the advent of surgical alternatives have made tracheostomy an unpopular solution to OSA, reserved for those patients with the most severe sleep apnea not manageable by other interventions.

The available evidence on hypoglossal nerve stimulation does not establish efficacy or reduce OSA severity, decrease incidence of clinical consequences, or reduce associated risk for occupational or motor vehicle accidents.

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