Medical Policy

Effective Date:08/03/2011 Title:Obstructive Sleep Apnea (OSA)
Revision Date:11/30/2020 Document:BI306:00
CPT Code(s):21198, 21199, 21208, 21209, 21685, 31600, 42145, 61886, 61888, 64568, 64569, 64570, 64585, 95800, 95801, 95803, 95805, 95806-95808, 95810, 95811, 95970, 95971, 95974, 95975, 0424T-0436T, 0466T, 0467T, 0468T, E0485, E0486, E0601, G0399, 95976, 95977
Public Statement

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.

Medical Statement

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:

21198

Reconstruct lower jaw segment

21199

Reconstruct lower jaw w/advance

21208

Augmentation of facial bones

21209

Reduction of facial bones

21685

Hyoid Myotomy & suspension

31600

Incision of windpipe

42145

Repair palate pharynx/uvula

61886

Insert/replace cranial neurostim pulse stim & connect to electrode arrays

61888

Revise/remove cranial neurostim pulse generator or receiver

64568

Implant cranial nerve (hypoglossal) neurostim array & pulse generator

64569

Revise/replace cranial neurostim array & pulse generator

64570

Remove cranial neurostim array & pulse generator

64585

Revise/remove peripheral neurostim electrode array

95800

Sleep study unattended

95801

Sleep study unattended w/analysis

95803

Actigraphy testing

95805

Multiple sleep latency test

95806

Sleep study unattended & resp efft

95807

Sleep study attended

95808

Polysomnography 1-3

95810

Polysomnography 4 or more

95811

Polysomnography w/CPAP titration

95970

Neurostim pulse generator device interrog

95971

Neurostim pulse generator device interrog + simple prog

95974

Neurostim pulse generator device interrog + complex prog 1st hr (Code term 01/01/2019 and replaced by 95976)

95975

       Device interrog + complx prog each additional 30 min (Code term 01/01/2019 and replaced by 95977)

 

 

0424T

Insrtn/rplcmt of neurostm syst for trmt of ctrl sleep apnea; compl syst

0425T

Insrtn/rplcmt of neurostm syst for trmt of ctrl sleep apnea; sensing lead only

0426T

Insrtn/rplcmt of neurostm syst for trmt of ctrl sleep apnea; stimul lead only

0427T

Insrtn/rplcmt of neurostm syst for trmt of ctrl sleep apnea; pulse gen only

0428T

Rmvl of neurostm syst for trmt of ctrl sleep apnea; pulse gen only

0429T

Rmvl of neurostm syst for trmt of ctrl sleep apnea; sensing lead only

0430T

Rmvl of neurostm syst for trmt of ctrl sleep apnea; stimulation lead only

0431T

Rmvl & rplcmt of neurostm syst for trmt of ctrl sleep apnea, pulse gen only

0432T

Repstn of neurostm syst for trmt of ctrl sleep apnea, stim lead only

0433T

Repstn of neurostm syst for trmt of ctrl sleep apnea, sensing lead only

0434T

Interrogation dvc eval implntd neurostm pulse gen syst for ctrl sleep apnea

0435T

Prgrm dvc eval of implntd neurostm pulse gen syst for ctrl sleep apnea; sgl session

0436T

Prgrm dvc eval of implntd neurostm pulse gen syst for ctrl sleep apnea; dur sleep study

0466T

Insert chest wall resp sensor & connection to pulse generator

0467T

Revise/replace chest wall resp sensor & connection to pulse generator

0468T

Remove chest wall resp sensor or electrode array

E0485

Oral dvc/appl used to reduce upper airway collapsibility, adjust or non-adjust, prefab,

incl fitting & adjstmt

E0486

Oral dvc/appl used to reduce upper airway collapsibility, adjust or non-adjust,

custom fabr, incl fitting & adjstmt

E0601

Continuous Positive Airway Pressure (CPAP) device

G0399

 

Home sleep study, unattended. Type III prtble monitor, min 4 channels, 2 resp mvmt/airflow, 1 ECG/HR, 1 O2 sat

 

95976 - Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with simple cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional

 

95977 - Electronic analysis of implanted neurostimulator pulse generator/transmitter (eg, contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with complex cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional

Limits

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.

Reference

1.    American Academy of Sleep Medicine, Standards of Practice Committee. Practice parameters for the use of auto-titrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea. Sleep. 2002; 25(2):143-147.

2.    Chesson AL, Jr, Berry RB, Pack A. Practice parameters for the use of portable monitoring devices in the investigation of suspected obstructive sleep apnea in adults. American Academy of Sleep Medicine. Sleep. 2003; 26(7):907-913.

3.    Agency for Healthcare Research and Quality (AHRQ), Technology Assessment Program. Effectiveness of portable monitoring devices for diagnosing obstructive sleep apnea: Update of a systematic review. Technology Assessment. Final Report. Prepared by RTI International for AHRQ. Rockville, MD: AHRQ: September 1, 2004.

4.    Hensley N, Ray C. Sleep apnoea. In: BMJ Clinical Evidence. London, UK: BMJ Publishing Group; May 2008.

5.    Kushida CA, Morgenthaler TI, Littner MR, et al.; American Academy of Sleep Medicine. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: An update for 2005. Sleep. 2006; 29(2):240-243.

6.    Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of obstructive sleep apnea. Health Care Guideline. 4th ed. Bloomington, MN: ISCI; March 2006.

7.    Ferguson K. Oral appliance therapy for obstructive sleep apnea: Finally evidence you can sink your teeth into. Am J Respir Crit Care Med. 2001; 163(6):1294-1295.

8.    Kushida CA, Littner MR, Hirshkowitz M, et al; American Academy of Sleep Medicine. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep. 2006; 29(3):375-380.

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13.   Vanderveken OM, Devolder A, Marklund M, et al. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. Am J Respir Crit Care Med. 2008; 178(2):197-202.

14.   Ferguson KA, Cartwright R, Rogers R, et al. Oral appliances for snoring and obstructive sleep apnea: A review. Sleep. 2006; 29(2):244-262.

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18.   Riley RW, Powell NB, Guilleminault C. Inferior mandibular osteotomy, and hyoid Myotomy suspension for obstructive sleep apnea. A review of 55 patients. J Oral Maxillofacial Surg. 1989; 47:159-164.

19.   Wright J, Johns R, Watt I, et al. Health effects of obstructive sleep apnea, and the effectiveness of continuous positive airways pressure: A systematic review of the research evidence. BMJ. 1997; 314(7084):851-860.

20.   Findley L, Smith C, Hooper J, et al. Treatment with nasal CPAP decreases automobile accidents in patients with sleep apnea. Am J Respir Crit Care Med. 2000; 161(3 Pt 1):857-859.

21.   Haniffa M, Lasserson TJ, Smith I. Interventions to improve compliance with continuous positive airway pressure for obstructive sleep apnoea. Cochrane Database Syst Rev. 2004 ;( 4):CD003531.

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27.   Pepin JL, Krieger J, Rodenstein D, et al. Effective compliance during the first 3 months of continuous positive airway pressure treatment. A European prospective study of 121 patients. Am J Respir Crit Care Med. 1999; 160(4):1124-1129.

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33.   Young T, Finn L, Peppard PE, et al. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008; 31(8):1071-1078.

34.   Marshall NS et.al. Sleep Apnea as an Independent Risk Factor for All-Cause Mortality: The Busselton Health Study. Sleep. 2008; 31(8):1079-1085.

35.   Hayes News Service.  FDA approves implantable Neurostimulator to treat sleep apnea.  7 May 2014.

36.   Malhotra A.  Hypoglossal-nerve stimulation for obstructive sleep apnea.  NEJM. 2014;370(2):170-171

37.   Strollo PJ et al. Upper-airway stimulation for obstructive sleep apnea.  NEJM 2014; 370(2):139-149.

38.   Rosen Carol L, et al. A multisite randomized trial of portable sleep studies and positive airway autotitration versus laboratory-based polysomnography for the diagnosis and treatment of Obstructive Sleep Apnea: The Home PAP Study. Sleep.  2012: 35(6): 757-767.

39.   Berry, Richard B, et al. "Portable monitoring and autotitration versus polysomnography for the diagnosis and treatment of sleep apnea." Sleep. 2008; 31(10): 1423-1431.

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Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer¡¯s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.