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Date Printed: June 26, 2017: 01:18 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-40000-16

Original Effective Date: 07/15/01

Reviewed: 01/22/15

Revised: 02/15/16

Subject: Medical & Surgical Management of Obstructive Sleep Apnea (OSA), Snoring, and Other Conditions of the Soft Palate and Nasal Passages (e.g., LAUP, UPPP, Somnoplasty, Coblation)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Treatment of obstructive sleep apnea (OSA), an interrupted breathing pattern occurring during sleep, involves both medical and surgical means. This policy addresses various methods for the management of OSA. CPAP, BiPAP, DPAP and Sleep Testing are addressed in separate policies.

Obstructive sleep apnea occurs more frequently in males and in those who are obese. Those with OSA often snore between apneic episodes, although all who snore do not have OSA. Underlying factors include both structural and physiological causes such as hypertrophied tonsillar tissue and inferior turbinate (coiled nasal bone). The frequent waking and sleeping cycles result in a sleep fragmentation, which may cause excessive daytime sleeping, leading to impairment of any activity. Severe OSA may be associated with decreased survival, presumably related to hypoxemia, hypertension or increased auto accidents from falling asleep while driving.

A polysomnogram is the typical diagnostic test and several indices are used to evaluate the patient. The final diagnosis is usually a result of a combination of objective and subjective criteria such as daytime sleepiness, the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale, consisting of a self-administered questionnaire asking patients to rank their likelihood of falling asleep in 8 different situations.

Medical management of OSA includes:

1. Weight loss,

2. Oral appliances, AND

3. Continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP).

Oral appliances can be categorized as mandibular advancing/positioning devices or tongue retaining devices. Oral appliances can either be “off the shelf” or custom made by a dental laboratory or similar provider, for the patient.

Surgical management of OSA includes:

1. Uvulopalatopharyngoplasty (UPPP),

2. Laser-assisted uvulopalatoplasty (LAUP) AND

3. Radiofrequency ablation of palatal tissue.

UPPP involves surgical resection of the mucosa and submucosa of the soft palate, tonsillar fossa, and the lateral aspect of the uvula. The amount of tissue removed is individualized for each patient as determined by the potential space and width of the tonsillar pillar mucosa between the 2 palatal arches. The UPPP enlarges the oropharynx but cannot correct obstructions in the hypopharynx. Thus patients who fail UPPP may be candidates for additional procedures, depending on the site of obstruction. Additional procedures include hyoid suspensions, maxillary and mandibular osteotomies, or modification of the tongue.

The LAUP procedure is an outpatient alternative that has been proposed as a treatment of snoring with or without associated OSA. In this procedure, superficial palatal tissues are sequentially reshaped using a carbon dioxide laser. The extent of the surgery is typically different than standard UPPP, since only part of the uvula and associated soft-palate tissues are reshaped. The procedure, as initially described, does not remove or alter tonsils or lateral pharyngeal wall tissues. The patient undergoes 3 to 7 sessions at 3 to 4 week intervals. One purported advantage of LAUP is that the amount of tissue ablated can be titrated such that the treatment can be discontinued once snoring is eliminated. The LAUP cannot be considered an equivalent procedure to the standard UPPP, with the laser simply representing a surgical tool that the physician may opt to use. LAUP is considered a unique procedure, raising unique issues of safety and particularly effectiveness.

NOTE: LAUP does not refer to the use of the laser as a tool in performing UPPP, but to a distinct and separate procedure typically performed over several surgical sessions in an outpatient setting.

Radiofrequency volumetric tissue reduction (i.e., Somnoplasty or Coblation) is similar conceptually to LAUP, with use of a different energy source in the form of radiofrequency ablation of palatal tissue and base of tongue. Radiofrequency ablation may be used to reduce excess tissues of the soft palate, uvula and tongue base (i.e., Somnoplasty) or nasal passages and soft palate (i.e., Coblation).

Palatal stiffening procedures include a cautery-assisted palatal stiffening operation (CAPSO) and insertion of palatal implants. The CAPSO procedure uses cautery to induce a midline palatal scar designed to stiffen the soft palate to eliminate excessive snoring. The Pillar™ Palatal Implant System (Restore Medical, St Paul, MN) is an implantable device that has been cleared by the FDA 510(k) process. The device is a cylindrical-shaped segment of braided polyester filaments that is permanently implanted in the submucosa of the soft palate. 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).”

The use of atrial overdrive pacing is also being evaluated in the treatment of OSA. This approach is being tried because of the bradycardia generally noted during episodes of apnea.

POSITION STATEMENT:

The following procedures or devices meet the definition of medical necessity when the associated criteria are met:

Intraoral appliances – in patients with clinically significant obstructive sleep apnea, as defined below in the Definitions section of this guideline. These devices may include either mandibular advancing/positioning devices or tongue retaining devices.

Uvulopalatopharyngoplasty (UPPP) – when performed for obstructive sleep apnea in appropriately selected patients with clinically significant obstructive sleep apnea, as defined below in the Definitions section of this guideline, and when other conservative treatment has been unsuccessful (i.e., weight reduction, avoidance of alcohol, modification of sleeping position, use of PAP devices, oral appliances). As stated in the Description section above, LAUP does not refer to the use of the laser as a tool in performing UPPP, but to a distinct and separate procedure typically performed over several surgical sessions in an outpatient setting.

Hyoid suspension, surgical modification of the tongue, or maxillofacial surgery, including mandibular-maxillary advancement (MMA), – in appropriately selected patients with clinically significant OSA and objective documentation of hypophyryngeal obstruction who have not responded to or do not tolerate CPAP.

Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency ablation of the tongue base, uvula or soft palate (i.e., Somnoplasty) is considered experimental or investigational for upper airway resistance syndrome or OSA as there is insufficient peer-reviewed literature to permit conclusions on how this treatment improves net health outcomes. Long-term clinical studies are lacking to support safety and efficacy of this procedure.

Radiofrequency ablation of the nasal passages, soft palate, tonsils, adenoids, or turbinates (i.e., Coblation) is considered experimental or investigational for the treatment of OSA and other sleep related breathing disorders as the published clinical evidence is insufficient to demonstrate safety and effectiveness.

Atrial pacing is considered experimental or investigational, as there is insufficient clinical evidence to support the effectiveness of this treatment in the treatment of OSA.

LAUP is considered experimental or investigational as a treatment for upper airway resistance syndrome or OSA as adequate controlled clinical studies on the LAUP procedure for sleep-related breathing disorders were not found in peer-reviewed journals.

Palatal stiffening procedures, including but not limited to, cautery-assisted palatal stiffening operation, and the implantation of palatal implants, are considered experimental or investigational as a treatment for upper airway resistance syndrome or OSA as there is insufficient clinical evidence to support efficacy.

All procedures or devices used for the treatment of snoring alone do not meet the definition of medical necessity as simple snoring in the absence of documented obstructive sleep apnea is not considered a medical condition.

Implantable hypoglossal nerve stimulators are considered experimental or investigational for all indications, including but not limited to the treatment of OSA. Additional studies with existing devices are needed to permit conclusions regarding the effect of this treatment on health outcomes.

BILLING/CODING INFORMATION:

The following codes may be used to describe UPPP, LAUP, radiofrequency ablation, or oral devices/appliances:

CPT Coding:

21199

Osteotomy, mandible, segmental; with genioglossus advancement

30801

Ablation, soft tissue of inferior turbinates, unilateral or bilateral, any method (e.g., electrocautery, radiofrequency ablation, or tissue volume reduction); superficial

30802

Ablation, soft tissue of inferior turbinates, unilateral or bilateral, any method (e.g., electrocautery, radiofrequency ablation, or tissue volume reduction); intramural (i.e., submucosal)

41512

Tongue base suspension, permanent suture technique

41530

Submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session (investigational)

42145

Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty, uvulopharyngoplasty)

42299

Unlisted procedure, palate, uvula

HCPCS Coding:

E0485

Oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, prefabricated fabricated, includes fitting and adjustment

E0486

Oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, custom fabricated, includes fitting and adjustment

S2080

Laser-assisted uvulopalatoplasty (LAUP) (investigational)

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

G47.30

Sleep apnea, unspecified

G47.33

Obstructive sleep apnea (adult) (pediatric

G47.39

Other sleep apnea

REIMBURSEMENT INFORMATION:

If the criteria is met as outlined in the section entitled POSITION STATEMENT and the service is otherwise a covered service under the individual’s contract with BCBSF, then the following reimbursement guidelines apply:

Reimbursement for oral appliances is limited to one (1) in a 12-month period. Services in excess of the limitation are subject to medical review of documentation supporting medical necessity (The following information may be required documentation to support medical necessity: physician history and physical, initial assessment, procedure note, visit note).

LOINC Codes:

DOCUMENTATION TABLE

LOINC CODES

LOINC TIME FRAME MODIFIER CODE

LOINC TIME FRAME MODIFIER CODES NARRATIVE

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician Initial Assessment

18736-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician procedure note

11505-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) was found at the time of the last guideline revised date.

The following Local Coverage Determinations (LCDs) were reviewed on the last guideline reviewed date: Noncovered Services, (L29288) and Sleep Testing (95805) located at fcso.com.

DEFINITIONS:

Clinically significant obstructive sleep apnea: defined as those patients meeting any of the following criteria:

1. AHI greater than or equal to 15, OR

2. AHI between 5 and 15 with ANY of the following associated symptoms:

• Excessive daytime sleepiness

• Impaired cognition

• Mood disorders

• Insomnia

• Documented hypertension

• Ischemic heart disease

• History of stroke.

RELATED GUIDELINES:

Sleep Testing, 01-95828-01
Continuous Positive Airway Pressure (CPAP); Bilevel Positive Airway Pressure (BiPAP); Demand Positive Airway Pressure (DPAP), 09-E0000-21

OTHER:

Other indexing terms:

Cautery-assisted Palatal Stiffening Operation
Laser-assisted uvulopalatoplasty (LAUP)
Mandibular-Maxillary Advancement (MMA)
Palatal Stiffening Procedure
Pillar Palatal Implant System
Radiofrequency Ablation of Palatal Tissue
Somnoplasty
Upper Airway Resistance Syndrome
Uvulopalatopharyngoplasty (UPPP)

REFERENCES:

  1. Agency for Healthcare Research and Quality. Comparative Effectiveness of Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. AHRQ Publication No. 11-EHC052-EF. (July, 2011).
  2. Agency for Healthcare Research and Quality. Comparative Effectiveness of Diagnosis and Treatment of Obstructive Sleep Apnea in Adults – Clinician Summary (08/08/2011).
  3. American Sleep Apnea Association website. OSA treatment options. Accessed 12/17/12.
  4. American Academy of Family Physicians. Victor LD. Treatment of obstructive sleep apnea in primary care. [Am Fam Physician 2004; 69:561-8,572-4].
  5. American Academy of Otolaryngology, Head and Neck Surgery website. Submucosal Ablation of the Tongue Base for OSAS. Accessed 12/28/12.
  6. American Academy of Pediatrics. Tonsillectomy Care for the Pediatrician. Pediatrics Vol. 130 No. 2 August 1, 2012. pp. 324 -334.
  7. American Academy of Sleep Medicine. Fact Sheet for Obstructive Sleep Apnea (2008). Accessed 12/17/12.
  8. American Academy of Sleep Medicine. Littner M, Kushida CA, Hartse K, Anderson WM, Davila D, Johnson SF, Wise MS, Hirshkowitz M, Woodson BT. Practice parameters for the use of laser-assisted uvulopalatoplasty: an update for 2000. [Sleep 2001 Aug 1; 24(5): 603-19].
  9. American Academy of Sleep Medicine. Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD, Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med 2009 Jun 15;5(3):263-76.
  10. American Sleep Disorders Association. Aurora RN, Casey KR, Kristo D, Auerbach S, Bista SR, Chowdhuri S, Karippot A, Lamm C, Ramar K, Zak R, Morgenthaler TI. Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep 2010 Oct 1;33(10):1408-13.
  11. Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM, American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30.
  12. Blue Cross Blue Shield Association Medical Policy Reference Manual. “Surgical Management of Obstructive Sleep Apnea Syndrome/Upper Airway Resistance Syndrome” 7.01.51, (archived).
  13. Blue Cross Blue Shield Association Medical Policy Reference Manual. “Diagnosis and Medical Management of Obstructive Sleep Apnea Syndrome” 2.01.18, 11/15.
  14. Blue Cross Blue Shield Association Medical Policy Reference Manual. Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome 7.01.101, 05/15.
  15. Blue Cross Blue Shield Association Technology Evaluation Center “Radiofrequency Volumetric Tissue Reduction for Sleep Related Breathing Disorders”, (12/00).
  16. Blue Cross Blue Shield Association Technology Evaluation Center “Surgical Procedures for the Treatment of Obstructive Sleep Apnea Syndrome”, (04/96).
  17. Blue Cross Blue Shield of Florida Technology Assessment Summary “Laser Assisted Uvulopalatoplasty (LAUP)”, (05/29/96).
  18. Carvalho FR, Lentini-Oliveira DA, Machado MAC, Saconato H, Prado LBF, Prado GF. Oral appliances and functional orthopaedic appliances for obstructive sleep apnoea in children. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD005520. DOI: 10.1002/14651858.CD005520.pub2.
  19. ClinicalTrials.gov, Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome (Verified by University Hospital, Rouen 09/05) (Identifier # NCT00213434).
  20. ECRI Hotline Article: “Clinical Criteria for Surgical Treatments for obstructive Sleep Apnea”, (10/11/05).
  21. ECRI Hotline Article: “Laser-Assisted Uvulopalatoplasty (LAUP) for Obstructive Sleep Apnea and Upper airway Resistance Syndrome”, 09/15/04).
  22. ECRI Hotline Article: “Palatal Implants for Obstructive Sleep Apnea (OSA)”, 10/21/04).
  23. ECRI Hotline Article: “Radiofrequency Mediated Tongue tissue Reduction (Somnoplasty) for Sleep Apnea”, (08/09/04).
  24. ECRI Hotline Response Article: “Palatal Implants for Obstructive Sleep Apnea (OSA)”, (05/22/06).
  25. ECRI Hotline Response Article: “Radiofrequency Volumetric Tissue Reduction (Somnoplasty) for Obstructive Sleep Apnea or Snoring”, (07/27/06).
  26. ECRI Hotline Response Article. “Radiofrequency Ablation for Treating Obstructive Sleep Apnea or Snoring”, (11/17/2011).
  27. ECRI Hotline Response Article: “Coblation versus Other Surgical Techniques for Tonsillectomy, (03/12/10).
  28. Florida Medicare Part B Medical Policy (First Coast Options, Inc). 95805, “Sleep Testing”, (retired 09/30/04).
  29. Florida Medicare, First Coast Service Options LCD L29288, Noncovered Services, (12/12/12).
  30. HAYES Medical Technology Directory. “Radiofrequency Volumetric Tissue Reduction for the Treatment of Upper Airway Obstruction”, (RADI0101.19 – 11/00; updated 10/18/04).
  31. HAYES Medical Technology Directory. “Sleep Apnea Treatment, Devices”, (09/16/99; updated 03/14/05).
  32. HAYES Medical Technology Directory. “Sleep Apnea Treatment, Medical”, (SLEE901.05) (11/28/97; updated 01/21/04).
  33. HAYES Medical Technology Directory. “Sleep Apnea Treatment, Surgical”, (SLEE0602.05) (03/14/05).
  34. Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD004435. DOI: 10.1002/14651858.CD004435.pub3.
  35. McKesson Health Solutions: InterQual® Care Planning Criteria, (2011).
  36. National Institute for Health and Clinical Excellence (NICE). Electrosurgery (diathermy and coblation) for tonsillectomy. Interventional Procedure Guidance 150. London, UK: NICE; December 2005. Accessed 01/27/14.
  37. Sundaram S, Bridgman SA, Lim J, Lasserson TJ. Surgery for obstructive sleep apnoea. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD001004. DOI: 10.1002/14651858.CD001004.pub2.
  38. U.S. Food and Drug Administration (FDA) Somnus Medical Technologies, Inc marketing approval for Somnoplasty System 07/17/97.
  39. Victor LD. Treatment of obstructive sleep apnea in primary care. [Am Fam Physician 2004; 69:561-8,572-4].

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/28/16.

GUIDELINE UPDATE INFORMATION:

05/17/01

MCG reformatted; revised to include information for somnoplasty.

01/01/02

Annual HCPCS coding update: added S2080.

06/15/02

Reviewed; clarification statement added for LAUP vs. laser-assisted UPPP; references updated.

02/15/03

Revised; added information regarding oral orthotic devices for treating OSA.

06/15/03

Reviewed; no changes.

06/15/04

Scheduled review, no revisions.

01/15/05

Annual HCPCS coding update (0088T added).

03/15/05

Scheduled review; no change in coverage statement; add procedure code 0088T.

10/15/05

Revision consisting of adding information regarding palatal stiffening procedures and hyoid suspension.

01/01/06

Annual HCPCS coding update: revise descriptor for 0088T. Add E0485 and E0486.

03/15/06

Scheduled review; no change in coverage statement; remove Program Exception for Medicare Advantage.

04/01/06

2nd Quarter HCPCS coding update: removed S8260.

03/15/07

Scheduled review; added information for atrial pacing; updated references, revised Description section.

06/15/07

Reformatted guideline; updated references.

04/15/08

Scheduled review; no change in position statement; updated ICD-9 coding section and references.

01/01/09

Annual HCPCS coding update: removed 0088T; added 41512 and 41530.

04/15/09

Scheduled review; added position statement regarding somnoplasty; reformatting changes; references updated.

01/01/10

Annual HCPCS coding update: simple revision to descriptor for 41530.

03/15/10

Revision of Position Statement to include additional coverage criteria for UPPP.

10/15/10

Revision; related ICD-10 codes added.

07/15/11

Revision; formatting changes.

03/15/12

Review; position statement revised to include information regarding coblation; references updated.

02/15/13

Review of position statement for Somnoplasty and Coblation; position statement revised for clarification; references updated.

03/15/14

Position statement for coblation reviewed with literature search; no change in position statement; Program Exceptions section updated; references updated.

02/15/15

Revision: added CPT codes 30801 and 30802.

07/30/15

Revision; position statement section and references updated.

11/01/15

Revision: ICD-9 Codes deleted.

02/15/16

Revision; position statement section updated.

Date Printed: June 26, 2017: 01:18 AM