MEDICAL POLICY 7.01.554

Surgical Treatment of Snoring and Obstructive Sleep

Apnea Syndrome

Effective Date: June 1, 2018

Last Revised: June 1, 2018

Replaces: N/A

RELATED MEDICAL POLICIES:

11.01.524 Site of Service: Select Surgical Procedures

Select a hyperlink below to be directed to that section.

POLICY CRITERIA | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

Obstructive sleep apnea (OSA) is a blockage in the upper part of the airway. The blockage is

usually from throat muscles collapsing, the tongue falling into the airway, or large tonsils or

adenoids getting in the way of airflow. Positive airway pressure (PAP) devices are very effective

in treating sleep apnea. A PAP device works by increasing air pressure in the throat to prevent it

from collapsing as a person breathes. When a PAP device doesnt work or there are certain other

medical situations, surgery can be a way to treat sleep apnea. There are a number of different

types of surgery, but they generally treat OSA by removing extra tissue in the throat to widen

the airway. There are also a number of other surgeries or devices that are still being studied.

They are not covered because there is not enough medical evidence to show they work. This

policy discusses when medically necessary surgeries for OSA may be approved.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

Policy Coverage Criteria

https://www.lifewisewa.com/medicalpolicies/11.01.524.pdf

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Site of service is defined as the location where the surgical procedure is performed, such as an

off campus-outpatient hospital or medical center, an on campus-outpatient hospital or medical

center, an ambulatory surgical center, or an inpatient hospital or medical center.

Site of Service for

Elective Surgical

Procedures

Medical Necessity

Medically necessary sites

of service:

Off campus-outpatient

hospital/medical center

On campus-outpatient

hospital/medical center

Ambulatory Surgical

Center

Certain elective surgical procedures will be covered in the most

appropriate, safe, and cost effective site. These are the

preferred medically necessary sites of service for certain

elective surgical procedures.

Inpatient hospital/medical

center

Certain elective surgical procedures will be covered in the most

appropriate, safe, and cost-effective site. This site is

considered medically necessary only when the patient has a

clinical condition which puts him or her at increased risk for

complications including any of the following (this list may not

be all inclusive):

Anesthesia Risk

o ASA classification III or higher (see definition)

o Personal history of complication of anesthesia

o Documentation of alcohol dependence or history of

cocaine use

o Prolonged surgery (>3 hours)

Cardiovascular Risk

o Uncompensated chronic heart failure (NYHA class III or IV)

o Recent history of myocardial infarction (MI) (

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Site of Service for

Elective Surgical

Procedures

Medical Necessity

Liver Risk

o Advance liver disease (MELD Score > 8)**

Pulmonary Risk

o Chronic obstructive pulmonary disease (COPD) (FEV1

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Treatment Medical Necessity have not responded to or do not tolerate nasal continuous

positive airway pressure (CPAP).

Note: Clinically significant OSA is defined in the Related Information section.

Hyoid suspension, surgical

modification of the tongue,

and/or maxillofacial

surgery

Hyoid suspension, surgical modification of the tongue, and/or

maxillofacial surgery, including mandibular-maxillary

advancement (MMA), may be considered medically necessary

in appropriately selected adult patients with clinically

significant OSA and objective documentation of

hypopharyngeal obstruction who have not responded to or do

not tolerate CPAP.

Note: Clinically significant OSA is defined in the Related Information section.

Adenotonsillectomy Adenotonsillectomy may be considered medically necessary in

pediatric patients with clinically significant OSA and

hypertrophic tonsils.

Note: Clinically significant OSA is defined in the Related Information section.

All interventions in the

absence of documented

OSA

All interventions, including LAUP (laser-assisted

uvulopalatoplasty), radiofrequency volumetric tissue

reduction of the palate, or palatal stiffening procedures are

considered not medically necessary for the treatment of

snoring in the absence of documented OSA; snoring alone is

not considered a medical condition.

Treatment Investigational Implantable hypoglossal

nerve stimulators

Implantable hypoglossal nerve stimulators are investigational

for all indications, including but not limited to the treatment

of obstructive sleep apnea (OSA).

Minimally-invasive surgical

procedures

The following minimally-invasive surgical procedures are

investigational for the sole or adjunctive treatment of OSA or

upper airway resistance syndrome (UARS):

Radiofrequency volumetric tissue reduction of the tongue (eg,

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Treatment Investigational Somnoplasty), with or without radiofrequency reduction of the

palatal tissues

Laser-assisted uvulopalatoplasty (LAUP) or radiofrequency

volumetric tissue reduction of the palatal tissues

Palatal stiffening procedures including, but not limited to,

cautery-assisted palatal stiffening operation (CAPSO), injection

of a sclerosing agent, and the implantation of palatal implants

(eg, Pillar Procedure)

Tongue base suspension (eg, Airvance System, formerly the

Repose Tongue and Hyoid Suspension System, Encore

system)

All other minimally-invasive surgical procedures not described

above

Coding

Code Description

CPT 0466T Insertion of chest wall respiratory sensor electrode or electrode array, including

connection to pulse generator (List separately in addition to code for primary

procedure)

0467T Revision or replacement of chest wall respiratory sensor electrode or electrode array,

including connection to existing pulse generator

21199 Osteotomy, mandible, segmental; with genioglossus advancement

41512 Tongue base suspension, permanent suture technique

41530 Submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session

42145 Palatopharyngoplasty (eg, uvulopalatopharyngoplasty, uvulopharyngoplasty)

42299 Unlisted procedure, palate, uvula

42950 Pharyngoplasty (plastic or reconstructive operation on pharynx)

64568 Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode

array and pulse generator

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Code Description

HCPCS

S2080 Laser-assisted uvulopalatoplasty (LAUP)

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

Continuous positive airway pressure is the preferred first-line treatment for most patients with

OSA. A smaller number of patients may use oral appliances as a first-line treatment (see Related

Policies).

The Apnea/Hypopnea Index is the total number events (apnea or hypopnea) per hour of

recorded sleep. The Respiratory Disturbance Index is the total number events (apnea or

hypopnea) per hour of recording time. An obstructive apnea is defined as at least a 10-second

cessation of respiration associated with ongoing ventilatory effort. Hypopnea is defined as an

abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in

thoracoabdominal movement or airflow compared with baseline, and with at least a 4% oxygen

desaturation.

Definition of Terms

American Society of Anesthesiologists (ASA) Score:

ASA 1 A normal healthy patient.

ASA 2 A patient with mild systemic disease.

ASA 3 A patient with severe systemic disease.

ASA 4 A patient with severe systemic disease that is a constant threat to life.

ASA 5 A moribund patient who is not expected to survive

New York Heart Association (NYHA) Classification:

Class I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath

when walking, climbing stairs etc.

Class II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during

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ordinary activity.

Class III Marked limitation in activity due to symptoms, even during less-than-ordinary

activity, eg, walking short distances (20100 m).Comfortable only at rest.

Class IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound

patients

Adults

The diagnosis of OSA in adults is confirmed by a sleep study result showing:

The apneic/hypopneic index (AHI) is greater than or equal to 15 events per hour, including a

minimum of 30 events documented per sleep study; or

The AHI is greater than or equal to 5 events per hour and less than 15 events per hour,

including a minimum of 10 events documented per sleep study, AND documentation of:

o History of stroke; or

o Hypertension (systolic blood pressure greater than 140 mm Hg and/or diastolic blood

pressure greater than 90 mm Hg); or

o Ischemic heart disease; or

o Symptoms of impaired cognition, mood disorders, or insomnia; or

o Excessive daytime sleepiness (documented by either Epworth greater than 10 or MSLT

less than 6); or

o Greater than 20 episodes of desaturation (ie, oxygen saturation of less than 85%) during

a full night sleep study, or any 1 episode of oxygen desaturation (ie, oxygen saturation of

less than 70%); or

o Obesity (BMI greater than 35)

OSA severity is defined as:

Mild for AHI 5/hr and < 15/hr.

Moderate for AHI 15/hr and < 30/hr.

Severe for AHI 30/hr.

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The AHI is the total number events (apnea or hypopnea) per hour of recorded sleep. An

obstructive apnea is defined as at least a 10-second cessation of respiration associated with

ongoing ventilatory effort. Hypopnea is defined as an abnormal respiratory event lasting at least

10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as

compared to baseline, and with at least a 4% oxygen desaturation.

Children

The presentation of OSA in pediatric patients may differ from that of adults.

The diagnosis of obstructive sleep apnea in children is established by a sleep study result

showing an apneic/hypopneic index (AHI) greater than 1.5. (An AHI of 1.5 is considered severe in

children.)

Upper airway resistance syndrome (UARS)

Clinically significant upper airway resistance syndrome (UARS) is defined as greater than 10 EEG

arousals per hour. The presence of abnormally negative intrathoracic pressures (ie, more

negative than 10 cm) in conjunction with the EEG arousals supports the diagnosis. The

measurement of intrathoracic pressures requires the use of an esophageal manometer as an

adjunct to a polysomnogram. Objective evidence of hypopharyngeal obstruction is documented

by either fiberoptic endoscopy or cephalometric radiographs.

Evidence Review

Description

Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway

obstruction due to the collapse of the upper airway during sleep. For patients who have failed

conservative therapy, established surgical approaches may be indicated. This policy addresses

minimally invasive surgical procedures for the treatment of OSA. They include laser-assisted

uvuloplasty, tongue base suspension, radiofrequency volumetric reduction of palatal tissues and

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base of tongue, palatal stiffening procedures, and hypoglossal nerve stimulation. This policy

does not address conventional surgical procedures such as uvulopalatopharyngoplasty, hyoid

suspension, surgical modification of the tongue, maxillofacial surgery, or adenotonsillectomy.

Background

Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway

obstruction due to the collapse and obstruction of the upper airway during sleep. In patients

with OSA, the normal pharyngeal narrowing may be accentuated by anatomic factors, such as a

short, fat bull neck, elongated palate and uvula, and large tonsillar pillars with redundant

lateral pharyngeal wall mucosa. In addition, OSA is associated with obesity. OSA may also be

associated with a variety of craniofacial abnormalities, including micrognathia, retrognathia, or

maxillary hypoplasia. Obstruction anywhere along the upper airway can result in apnea.

The hallmark symptom of OSA is excessive daytime sleepiness, and the typical clinical sign of

OSA is snoring, which can abruptly cease and be followed by gasping associated with a brief

arousal from sleep. The snoring resumes when the patient falls back to sleep, and the cycle of

snoring/apnea/arousal may be repeated as frequently as every minute throughout the night.

Sleep fragmentation associated with the repeated arousal during sleep can lead to impairment

of daytime activity. For example, adult patients with OSA-associated daytime somnolence are

thought to be at higher risk for accidents involving motorized vehicles, ie, cars, trucks, or heavy

equipment. OSA in children may result in neurocognitive impairment and behavioral problems.

In addition, OSA affects the cardiovascular and pulmonary systems. For example, apnea leads to

periods of hypoxia, alveolar hypoventilation, hypercapnia, and acidosis. This in turn can cause

systemic hypertension, cardiac arrhythmias, and cor pulmonale. Systemic hypertension is

common in patients with OSA. Severe OSA is also associated with decreased survival,

presumably related to severe hypoxemia, hypertension, or an increase in automobile accidents

related to overwhelming sleepiness.

The evidence on hypoglossal nerve stimulation for the treatment of OSA includes case series

and one prospective cohort of about 100 patients followed for 3 years. For patients who had

failed conservative therapy and met the inclusion criteria for AHI, BMI, and favorable pattern of

palatal collapse, about two-thirds met the study definition of success. Results observed at the

12-month follow-up were maintained at 3 years. However, the comparative efficacy of this

procedure relative to established OSA treatment options is uncertain. Additional study

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comparing hypoglossal nerve stimulation to established surgical procedures is needed to permit

conclusions on the effect of this treatment on health outcomes.

Summary of Evidence

For individuals who have obstructive sleep apnea (OSA) who receive laser-assisted

uvulopalatoplasty, tongue base suspension, radiofrequency volumetric reduction of palatal

tissues and base of tongue, palatal stiffening procedures, or hypoglossal nerve stimulation, the

evidence includes case series, cohort studies, and randomized controlled trials (RCTs). Relevant

outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity.

The evidence on nearly all of the minimally invasive surgical procedures reviewed herein has

shown limited efficacy in patients with mild-to-moderate OSA and has not improved Apnea-

Hypopnea Index (AHI) or excessive daytime sleepiness in adults with moderate-to-severe OSA.

Hypoglossal nerve stimulation has shown improved outcomes in single arm studies when used

in a very select group of patients. In the largest study to date, two-thirds of patients who met

inclusion criteria for AHI, body mass index, and favorable pattern of palatal collapse met the

study definition of success. However, the role of nerve stimulation among the surgical

procedures for OSA treatment is uncertain. RCTs comparing hypoglossal nerve stimulation to

conventional surgical procedures are needed to evaluate benefits and harms. The evidence is

insufficient to determine the effects of the technology on health outcomes.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No. Trial Name Planned

Enrollment

Completion

Date

Ongoing

NCT02907398a Adherence and Outcome of Upper Airway

Stimulation (UAS) for OSA International Registry

2500 Sep 2019

https://www.clinicaltrials.gov/ct2/show/NCT02907398?term=NCT02907398&rank=1

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NCT No. Trial Name Planned

Enrollment

Completion

Date

NCT02263859a ImThera Medical Targeted Hypoglossal

Neurostimulation Study #3 (THN3)

141 May 2021

NCT02413970 Inspire Upper Airway Stimulation System (UAS):

Post-Approval Study Protocol Number 2014-001

127 Dec 2021

Unpublished

NCT01446601a Pivotal Study of the Apnex Medical Hypoglossal

Nerve Stimulation (HGNS) System to Treat

Obstructive Sleep Apnea

132 Aug 2013

(terminated)

NCT02293746a Inspire Upper Airway Stimulation (UAS) System

German Post-Market Study: CE Certificate

Number 562872

60 Jan 2017

(completed)

NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

American Academy of Sleep Medicine (AASM)

The American Academy of Sleep Medicine (AASM) published practice parameters for surgical

modifications of the upper airway for obstructive sleep apnea (OSA) in 2010.23 AASM practice

parameters were based on a systematic review of the evidence that found that the published

literature was comprised primarily of case series, with few controlled trials and varying

approaches to preoperative evaluation and postoperative follow-up.24 Using the change in

Apnea-Hypopnea Index (AHI) as the primary measure of efficacy, substantial and consistent

reductions were observed following mandibular-maxillary advancement (MMA), and adverse

events were uncommonly reported. Outcomes following pharyngeal surgeries were less

consistent, and adverse events were more commonly reported. The review found that outcomes

of studies with newer pharyngeal techniques and multilevel procedures, performed in small

numbers of patients, appear promising. The practice parameters noted the lack of rigorous data

evaluating surgical modifications of the upper airway, resulting in a recommendation of option

(uncertain clinical use) for MMA, uvulopalatopharyngoplasty (UPPP) as a sole procedure, or

multilevel or stepwise surgery if patients failed UPPP as a sole treatment. Use of radiofrequency

ablation was recommended as an option for patients with mild-to-moderate OSA who cannot

tolerate or are unwilling to adhere to continuous positive airway pressure (CPAP), or in whom

https://www.clinicaltrials.gov/ct2/show/NCT02263859?term=NCT02263859&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02413970?term=NCT02413970&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01446601?term=NCT01446601&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02293746?term=NCT02293746&rank=1

Page | 12 of 18

oral appliances have been found ineffective or undesirable. Palatal implants were recommended

as an option for patients with mild OSA who failed medical therapy. Laser-assisted

uvulopalatoplasty was not recommended as a routine treatment for OSA (standard). The

practice parameters recommended as standard the need to determine the presence and

severity of OSA before initiating surgical therapy, discussion of success rates, complications, and

alternative treatments with the patient, and a postoperative follow-up evaluation, which includes

a clinical evaluation and an objective measure of the presence and severity of sleep-disordered

breathing and oxygen saturation. However, little guidance was available in the medical literature

to recommend any particular monitoring strategy. The optimal interval and duration of this

follow-up were also not clear from the available literature.

The American Academy of Pediatrics (AAP)

The AAP published a 2012 clinical practice guideline on the diagnosis and management of

childhood OSA.25 AAP recommends that if a child has OSA, a clinical examination consistent with

adenotonsillar hypertrophy, and does not have a contraindication to surgery, the clinician

should recommend adenotonsillectomy as the first line of treatment. AAP recommends that

patients should be referred for CPAP management if symptoms/signs or objective evidence of

OAS persists after adenotonsillectomy or if adenotonsillectomy is not performed. Weight loss

should be recommended in addition to other therapy if a child/adolescent with OSA is

overweight or obese

The American Academy of Otolaryngology - Head and Neck Surgery

(AAO-HNS)

The 2016 American Academy of Otolaryngology-Head and Neck Surgery position statement on

hypoglossal nerve stimulation for treatment of obstructive sleep apnea (OSA)26 states: 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 patients 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.

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The American Academy of OtolaryngologyHead and Neck Surgery (AAO-HNS) has a 2014

revised policy statement on surgical management of OSA.26 Procedures AAO-HNS supported as

effective and not considered investigational when part of a comprehensive approach in the

medical and surgical management of adults with OSA include tracheotomy, nasal and

pharyngeal airway surgery, tonsillectomy and adenoidectomy, palatal advancement, UPPP,

uvulopalatoplasty (including laser- assisted and other techniques), genioglossal advancement,

hyoid myotomy, midline glossectomy, tongue suspension, and maxillary and mandibular

advancement.

In its 2012 position statement on UPPP, AAO-HNS concluded that UPPP is a valid treatment of

OSA. Simultaneous and serial surgical procedures were considered medically necessary and

effective for patients with mild to severe obstructive sleep apnea.27 Another 2012 position

statement recommended tongue suspension as effective when considered as part of a

comprehensive approach in the medical and surgical management of adult patients with mild

OSA and in adult patients with moderate and severe OSA who have evidence of tongue base or

associated hypopharyngeal obstruction.28 AAO-HNS notes that results appear to diminish in

obese patients, and this technique should receive a weaker recommendation for these patients.

In 2011, AAO-HNS published clinical practice guidelines on polysomnography (PSG) for sleep-

disordered breathing before tonsillectomy in children.29 In addition to recommendations for PSG

(see Related Policies), AAO-HNS made the following recommendation: clinicians should admit

children with OSA documented on PSG for inpatient, overnight monitoring after tonsillectomy if

they are younger than age 3 years or have severe OSA (AHI 10, oxygen saturation nadir

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Medicare National Coverage

In 2001, the Centers for Medicare and Medicaid Services (CMS) published a decision

memorandum for CPAP that addressed the issue of how to define moderate to severe OSA as a

guide to a coverage policy for CPAP.31 Since surgical approaches are considered when CPAP

fails, the Medicare policy has been adapted to this policy on surgical management of OSA. The

Medicare review of the literature suggested that there is a risk of hypertension with an AHI

greater than 15, and thus treatment is warranted for these patients without any additional signs

and symptoms. For patients with an AHI between 5 and 15 and associated symptoms, the CMS

document concluded that the data from 3 RCTs demonstrated improved daytime somnolence

and functioning in those treated with CPAP.

Regulatory Status

In 1998, the Somnoplasty device was cleared for marketing by the U.S. Food and Drug

Administration (FDA) through the 510(k) process for radiofrequency ablation of palatal tissues

for simple snoring and for the base of the tongue for obstructive sleep apnea (OSA). FDA

product code: GEI.

In 1999, AIRvance (Medtronic; formerly the Repose Bone Screw System from Influence) was

cleared for marketing by the FDA though the 510(k) process for anterior tongue base

suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone

screw with prethreaded suture. It is indicated for the treatment of OSA and/or snoring. In 2011,

the Encore Tongue Suspension System (Siesta Medical) was cleared for marketing by the FDA

though the 510(k) process. The FDA determined that this device was substantially equivalent to

the PRELUDE III Tongue Suspension System (Siesta Medical). FDA product codes: LRK, ORY.

The Pillar Palatal Implant System (Restore Medical, St. Paul, MN, acquired by Medtronic,

Minneapolis, MN), an implantable device, was cleared for marketing by the FDA through the

510(k) process. The labeled indication of the device is as follows: The Pillar Palatal Implant

System is intended for the reduction of the incidence of airway obstructions in patients suffering

from mild to moderate OSA (obstructive sleep apnea). FDA product code: LRK.

In 2014, the Inspire II Upper Airway Stimulation System (Inspire Medical Systems) was

approved by the FDA through the premarket approval process. In 2011, Apnex Medical received

FDA approval to conduct a randomized investigational device exemption (IDE) trial for the

Hypoglossal Nerve Stimulation (HGNS) System. The trial was terminated and Apnex Medical

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has ceased operations. In 2014, ImThera Medical received FDA approval to conduct an IDE trial

with the aura6000.

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28. American Academy of Otolaryngology-Head and Neck Surgery. Position Statement on Uvulopalatopharyngoplasty. 2012;

http://www.entnet.org/?q=node/896 Accessed May 2018.

29. American Academy of Otolaryngology-Head and Neck Surgery. Position Statement on Tongue Suspension. 2012;

http://www.entnet.org/Practice/policytonguesuspension.cfm Accessed May 2018.

30. Roland PS, Rosenfeld RM, Brooks LJ, et al. Clinical practice guideline: Polysomnography for sleep-disordered breathing prior to

tonsillectomy in children. Otolaryngol Head Neck Surg. Jul 2011;145(1 Suppl):S1-15. PMID 21676944

31. American Society for Metabolic & Bariatric Surgery. Peri-operative management of obstructive sleep apnea. 2012

http://asmbs.org/resources/peri-operative-management-of-obstructive-sleep-apnea Accessed May 2018.

32. Centers for Medicare and Medicaid. Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive

Sleep Apnea (OSA) (CAG-00093N). 2001, Oct 30. http://www.cms.gov/medicare-coverage-database/details/nca-decision-

memo.aspx?NCAId=19&ver=7&NcaName=Continuous+Positive+Airway+Pressure+(CPAP)+Therapy+for+Obstructive

+Sleep+Apnea+(OSA)&TAId=50&bc=AAAAAAAAEAAA& Accessed May 2018.

33. Blue Cross and Blue Shield Association. Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome. Medical Policy

Reference Manual, policy 7.01.101, 2016.

http://www.entnet.org/Practice/policySurgicalMgmtApnea.cfmhttp://www.entnet.org/content/position-statement-hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osahttp://www.entnet.org/content/position-statement-hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osahttp://www.entnet.org/?q=node/896http://www.entnet.org/Practice/policytonguesuspension.cfmhttp://asmbs.org/resources/peri-operative-management-of-obstructive-sleep-apneahttp://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=19&ver=7&NcaName=Continuous+Positive+Airway+Pressure+(CPAP)+Therapy+for+Obstructive+Sleep+Apnea+(OSA)&TAId=50&bc=AAAAAAAAEAAA&http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=19&ver=7&NcaName=Continuous+Positive+Airway+Pressure+(CPAP)+Therapy+for+Obstructive+Sleep+Apnea+(OSA)&TAId=50&bc=AAAAAAAAEAAA&http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=19&ver=7&NcaName=Continuous+Positive+Airway+Pressure+(CPAP)+Therapy+for+Obstructive+Sleep+Apnea+(OSA)&TAId=50&bc=AAAAAAAAEAAA&

Page | 17 of 18

History

Date Comments 07/14/14 New PR policy replacing 7.01.101. Medically necessary criteria for OSA diagnosis

expanded to include a threshold of an AHI of 15-30 events as a specific criterion.

When the AHI is 5-15, an additional requirement of documentation to evidence:

stroke, hypertension, ischemic heart disease; or, symptoms of impaired

cognition/mood disorder/insomnia; or, Epworth sleep scale greater than 10 or MSLT

less than 6 to evidence daytime sleepiness; or, more than 20 episodes of desaturation;

or obesity (BMI over 35). When the AHI is greater than 30, the patient must be able to

tolerate PAP or it must be contraindicated. Criteria for children updated to an

apneic/hypopneic index (AHI) greater than 1.5. ICD-9 and ICD-10 procedure and

diagnosis codes removed; they are not utilized in adjudication. Policy effective

subsequent to 2.01.532 effective October 23, 2014. Added investigational policy

statement for implantable hypoglossal nerve stimulators.

10/23/14 Reissue policy as updates are now effective; reference to previous version removed.

06/17/15 Annual Review. No change to policy statements. Informational CPT codes removed;

these are not reviewed.

02/09/16 Annual Review. Policy updated with literature review through January, 2016; reference

31 added; policy statements unchanged.

03/01/17 Annual Review, approved February 14, 2017. Policy updated with literature review

through October 4, 2016; references 17-20 added. Coding update; added codes,

including new CPT codes effective 1/1/17. No change to policy statements.

03/30/17 Policy moved into new format; no change to policy statements.

12/01/17 Interim Review, approved November 9, 2017. Policy updated with literature review

through July 20, 2017; reference 27 added, references 26,28, 29, 31, updated. Policy

statements unchanged. Removed CPT code 0468T.

01/01/18 Removed Related Policies 1.01.524, 2.01.503, and 2.01.532 as they were archived.

03/01/18 Interim Review, approved February 27, 2018. Note added that this policy has been

revised. Added Surgery Site of Service criteria, which becomes effective June 1, 2018.

06/01/18 Minor update; removed note and link to updated policy. Surgery Site of Service criteria

becomes effective.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

Page | 18 of 18

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). 2018 Premera

All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

037336 (07-2016)

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