Local Coverage Determination (LCD)

Surgical Treatment of Obstructive Sleep Apnea (OSA)

L34526

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34526
Original ICD-9 LCD ID
Not Applicable
LCD Title
Surgical Treatment of Obstructive Sleep Apnea (OSA)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 07/27/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description

Bi-annual review was completed with no change in coverage.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

CMS Pub. 100-02 Medicare Benefit Policy Manual Chapter 15 §70- Sleep Disorder Clinics;
Chapter 16 §140 Dental Services Exclusion

CMS Pub. 100-03 Medicare National Coverage Determinations Manual Chapter 1, Part 4 §240.4 Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA)

Social Security Act 1862 (a)(1)(A) Medically Reasonable & Necessary.

Social Security Act 1862 (a)(1)(D) Investigational or Experimental.

CMS Transmittal No, 857, effective date October 3, 2018 Change Request 10901 Local Coverage Determinations (LCDs) Implementation date January 8, 2019.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Sleep-Disordered Breathing, often referred to as Obstructive Sleep Apnea (OSA), is characterized by frequent episodes of hypopnea or apnea during sleep. Multiple detrimental physiologic changes may result from these hypopneic and apneic episodes. Non-surgical and surgical approaches to obstructive apnea and hypopnea have been developed.

Continuous Positive Airway Pressure (CPAP) breathing is the treatment of choice for OSA. Some patients do not tolerate CPAP or are not benefited from it. The level of obstruction in OSA (retropalatal, retrolingual, and retropalatal and retrolingual) is variable.

Uvulopalatopharyngoplasty (UPPP) is an accepted means of surgical treatment for this disorder but is curative in less than 50% of patients. Scientific evidence suggests that UPPP is useful in retropalatal and combination retropalatal and retrolingual obstruction.

Mandibular Maxillary Osteotomy and Advancement is a procedure developed for those patients with retrolingual obstruction, or those patients with retropalatal and retrolingual obstruction who have not responded to CPAP and uvulopalatopharyngoplasty. Medical data on the efficacy of this treatment has been reported from only a small number of centers, but the information appears to show good results for those patients who meet certain criteria. It is unknown whether the technique will result in similar results outside specialized centers.

Tracheostomy remains the surgical approach with the greatest effectiveness since it bypasses all areas of obstruction in the nasal, palatal, lingual, and pharyngeal areas. However, tracheostomy is associated with significant morbidity, and is usually reserved for patients who have failed other medical or surgical methods of treatment, or who are unsuitable for other methods of treatment for various reasons.

Various other anatomic abnormalities (such as, but not limited to, enlarged tonsils or tongue) sometimes cause OSA also. Surgical approaches to these abnormalities will vary according to the anatomic defect and the procedure/procedures needed to correct the defined problem.

Genioglossal advancement, with or without resuspension of the hyoid bone, may be performed with uvulopalatopharyngoplasty, but this procedure is not always successful, and there is little definitive information on its benefit.

  1. Uvulopalatopharyngoplasty (UPPP) is covered for those patients who have all of the following:
    1. Obstructive sleep apnea diagnosed (prior to any proposed surgery) in a certified sleep disorders laboratory (certification body recognized by the American Academy of Sleep Medicine);
    2. A Respiratory Disturbance Index of 15 or higher;
    3. Failed to respond to Continuous Positive Airway Pressure therapy or cannot tolerate CPAP or other appropriate non-invasive treatment;
    4. Documented counseling by a physician, with recognized training in sleep disorders, about the potential benefits and risks of the surgery; and
    5. Evidence of retropalatal or combination retropalatal/retrolingual obstruction as the cause of the obstructive sleep apnea.
  2. Mandibular Maxillary Osteotomy and Advancement and /or genioglossus advancement with or without hyoid suspension is covered for those patients who have all of the following:
    1. Obstructive sleep apnea diagnosed (prior to any proposed surgery) in a certified sleep disorders laboratory (certification body recognized by the American Academy of Sleep Medicine);
    2. A Respiratory Disturbance Index of 15 or higher;
    3. Failed to respond to Continuous Positive Airway Pressure therapy or cannot tolerate CPAP or other appropriate non-invasive treatment;
    4. Documented counseling by a physician, with recognized training in sleep disorders, about the potential benefits and risks of the surgery; and
    5. Evidence of retrolingual obstruction as the cause of the obstructive sleep apnea, or previous failure of UPPP to correct the obstructive sleep apnea.
      Regarding the Mandibular Maxillary Osteotomy and Advancement operation:
      1. Separate repositioning of teeth would not be necessary except under unusual circumstances; but if necessary, the dental work would be covered.
      2. Application of an interdental fixation device is occasionally necessary and is a covered service (see Documentation Requirements).
  3. Tracheostomy is covered for obstructive sleep apnea that is in the judgment of the attending physician, unresponsive to other means of treatment or in cases where other means of treatment would be ineffective or not indicated.
  4. When obstructive sleep apnea is caused by discrete anatomic abnormalities of the upper airway (such as, but not limited to, enlarged tonsils or an enlarged tongue), surgery to correct these abnormalities is covered if medically necessary based on adequate documentation in the medical records supporting the significant contribution of these abnormalities to OSA. Submucous radiofrequency reduction of hypertrophied turbinates is covered as an appropriate treatment for nasal obstruction due to turbinate hypertrophy that significantly contributes to OSA or significantly compromises CPAP therapy.
  5. The following procedures are not covered at this time.
    1. Laser-assisted uvulopalatoplasty (LAUP) is not covered at this time since it is not considered effective for OSA.
    2. Somnoplasty™ is a trade name for palate reduction with the Somnoplasty™ System of Somnus Medical Systems. This is not a term recognized by this Contractor as a covered procedure under Medicare Part B. 
    3. The Pillar Procedure™ is a trade name for palatal implants. Palatal implants have not  been shown effective for the treatment of obstructive sleep apnea and are not covered.
    4. Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session. will be denied as investigational and experimental.
Summary of Evidence

NA

Analysis of Evidence (Rationale for Determination)

NA

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements
Physicians' Services and diagnostic tests/x-rays must be submitted with a diagnosis code to support medical necessity and must be coded to the greatest level of specificity and the highest level of digit completeness. The precise diagnosis code that most fully explains the narrative diagnosis contained in the medical record or test interpretation/report is expected. The diagnosis code based on the results of the test should be the primary diagnosis. If the test results are normal or inconclusive the diagnosis code representing the sign, symptom, illness or injury prompting the ordering of the test/x-ray should be reported as the primary diagnosis. In the absence of signs, symptoms, illness or injury, a screening diagnosis code should be reported, and payment will be denied.

The patient's medical records must be legible, contain the relevant history, and physical findings conforming to the criteria listed under the "Coverage Indications, Limitations, and/or Medical Necessity" section, and must be made available to the contractor upon request.

Documentation of the counseling of the risks and benefits of the procedure must be included in the patient's medical records and must be made available to the contractor on request.

Documentation of adequate trial of CPAP or other modes of continuous positive airway pressure therapy for obstructive sleep apnea under the care of a physician specifically trained in sleep disordered breathing must also be included in the patient's medical record and must be made available to the contractor on request. Absence of this information could result in denial.

After adequate healing of the surgical site, a follow-up evaluation by a physician with recognized training in sleep disorders is recommended and should be documented accordingly.

Sources of Information
N/A
Bibliography

Aurora, R. N., Casey, K.R., & et al. (2010). Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. SLEEP, 33(10): 1408-13.

Caples, S.M., Rowley, J.A., & et al. Surgical modifications of the upper airway for obstructive sleep apnea in adults: A systematic review and meta-analysis. SLEEP, 33(10):1396-1407.

Larrosa, F., Hernandez, L., & et al. (July, 2004). Laser-assisted uvulopalatoplasty for snoring: does it meet the expectations? European Respiratory Journal, (1):66-70.

Littner, M., Kushida, C., & et.al. Practice parameters for the use of laser-assisted uvulopalatoplasty: An update for 2000. SLEEP, 24(5).

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
07/27/2023 R10

Posted 07/27/2023-Under CMS National Coverage Policy italicized font removed.
Minor punctuation changes made and bibliography updated to AMA format. No change in coverage. Review completed 06/13/2023.

  • Other (Review)
07/29/2021 R9

07/29/2021 Moved sources of information to bibliography. Punctuation errors were corrected throughout the LCD. Review completed 6/18/2021.

  • Other (Review)
11/01/2019 R8

Content has been moved to the new template.

  • Revisions Due To Code Removal
08/29/2019 R7

08/29/2019 Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS and ICD-10 codes have been removed from this LCD and placed in Billing and Coding: Surgical Treatment of Sleep Apnea (OSA) linked to this LCD. Consistent with Change Request 10901 language from IOMs and/or regulations has been removed and the applicable manual/regulation has been reference. Review completed 08/05/2019. There will not be a lapse in coverage and there has been no change to the coverage content of this LCD.

  • Other (Changes in response to CMS Change Request 10901, review completed. )
12/01/2018 R6

12/01/2018 Annual review completed 11/05/2018. No change in coverage.

 

  • Other (Annual Review)
01/01/2018 R5

01/01/2018: Annual review completed 12/01/2017. Grammatical corrections made. No change in coverage. At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review )
01/01/2017 R4 01/01/2017: Annual review completed 12/02/2016, typographical corrections
  • Typographical Error
  • Other (2017 Annual Review, typographical corrections )
02/01/2016 R3 02/01/2016- Annual review completed 01/04/2016. Removed ICD-9 references & CAC information & reformatted source of information section.
  • Other ((Annual Review))
10/01/2015 R2 10/06/2015 - Due to CMS guidance, we have removed the Jurisdiction 8 Notice and corresponding table from the CMS National Coverage Policy section. No other changes to policy or coverage.
  • Other
10/01/2015 R1 03/01/2015-Annual review 01/09/2015, no change to coverage; updated source of information section.
  • Other (Annual Review)
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Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
07/19/2023 07/27/2023 - N/A Currently in Effect You are here
07/20/2021 07/29/2021 - 07/26/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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