Local Coverage Determination (LCD)

Oral Appliances for Obstructive Sleep Apnea

L33611

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Contractor Information

LCD Information

Document Information

LCD ID
L33611
LCD Title
Oral Appliances for Obstructive Sleep Apnea
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33611
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 08/08/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
06/24/2021
Notice Period End Date
08/07/2021
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2020 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 © 2020 American Dental Association. All rights reserved.

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CMS National Coverage Policy

N/A

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

  • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  • Refer to the Supplier Manual for additional information on documentation requirements.
  • Refer the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

A custom fabricated mandibular advancement oral appliance (E0486) used to treat obstructive sleep apnea (OSA) is covered if criteria A - D are met.

  1. The beneficiary has an in-person clinical evaluation by the treating practitioner prior to the sleep test to assess the beneficiary for obstructive sleep apnea testing. Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.
  2. The beneficiary has a Medicare-covered sleep test that meets one of the following criteria (1 - 3):
    1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or,
    2. The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:
      1. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
      2. Hypertension, ischemic heart disease, or history of stroke; or,
    3. If the AHI> 30 or the RDI> 30 and meets either of the following(a or b):
      1. The beneficiary is not able to tolerate a positive airway pressure (PAP) device; or,
      2. The treating practitioner determines that the use of a PAP device is contraindicated.
  3. The device is ordered by the treating practitioner following a review of the report of the sleep test. (The practitioner who provides the order for the oral appliance could be different from the one who performed the clinical evaluation in criterion A.)
  4. The device is provided and billed for by a licensed dentist (DDS or DMD).

If all of these criteria (A-D) are not met, the custom fabricated oral appliance (E0486) will be denied as not reasonable and necessary.

Refer to the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section of the Policy Article for information about coverage for appliances that achieve their effect through positioning of the tongue (A9270).

A prefabricated oral appliance (E0485) will be denied as not reasonable and necessary. There is insufficient evidence to show that these items are effective therapy for OSA.

Definitions

As used in this policy, treating practitioner refers to a licensed MD, DO, nurse practitioner, clinical nurse specialist, or physician's assistant working within their scope of practice. The term treating practitioner does not include a dentist (DDS or DMD).

Apnea is defined as the cessation of airflow for at least 10 seconds.

Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation.

The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the AHI. Sleep time can only be measured in a Type I (facility-based polysomnogram) or Type II sleep study (see descriptions below).

The respiratory disturbance index (RDI) is defined as the average number of apneas plus hypopneas per hour of recording without the use of a positive airway pressure device. For purposes of this policy, respiratory effort related arousals (RERAs) are not included in the calculation of the RDI. The RDI is reported in Type III, Type IV, and Other home sleep studies.

If the AHI or RDI is calculated based on less than 2 hours of sleep or recording time, the total number of recorded events used to calculate the AHI or RDI (respectively) must be at least the number of events that would have been required in a 2-hour period (i.e., must reach >30 events without symptoms or >10 events with symptoms). Projections of AHI or RDI based upon shorter testing times and/or fewer events are not acceptable for use in determining eligibility for payment.

Sleep Tests

Coverage and payment rules for diagnostic sleep tests may be found in the CMS National Coverage Determination (NCD) 240.4.1 (CMS Pub. 100-03, Chapter 1, Part 4), the applicable A/B MAC LCDs and Billing and Coding articles.

Coverage of an oral appliance for the treatment of OSA is limited to claims where the diagnosis of OSA is based upon a Medicare-covered sleep test. The sleep test must be either a polysomnogram performed in a facility-based laboratory (Type I study) or an inpatient hospital-based or home-based sleep test (HST) (Types II, III, IV, Other).

Coverage of an oral appliance device for the treatment of OSA is limited to claims where the diagnosis of OSA is based upon all of the following:

  1. A sleep test (Type I, II, III, IV, Other) that meets the Medicare requirements for a valid sleep test as outlined in NCD 240.4.1 and the applicable A/B MAC LCD and Billing and Coding article; and,
  2. A sleep test that is approved by the Food and Drug Administration (FDA) as a diagnostic device; and,
  3. The sleep test results meet the coverage criteria in effect for the date of service of the claim for the oral appliance device; and,
  4. The sleep test is ordered by the beneficiary’s treating practitioner; and,
  5. The sleep test is conducted by an entity that qualifies as a Medicare provider of sleep tests and is in compliance with all applicable state regulatory requirements.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

Summary of Evidence

Analysis of the Medicare Coverage Database indicates that the A/B MAC contractors have LCDs and Billing and Coding articles that address the coverage, coding and payment rules for diagnostic sleep testing. Furthermore, CMS addresses diagnostic sleep testing device requirements in the CMS National Coverage Determination (NCD) 240.4.1 (CMS Pub. 100-03, Chapter 1, Part 4).

 

Analysis of Evidence (Rationale for Determination)

The DME MACs received a reconsideration request that prompted an analysis of the language in NCD 240.4.1 and the A/B MAC policies (LCDs and Billing and Coding articles). After that analysis, we determined that the home sleep test information in the Oral Appliances for Obstructive Sleep Apnea (L33611) was duplicative. Due to the jurisdictional assignment for coverage and payment of diagnostic sleep testing to the A/B MAC contractors, the DME MACs have elected to remove sleep testing requirements from the DME MAC Oral Appliances for Obstructive Sleep Apnea LCD. Coverage of oral appliance devices for the treatment of OSA will continue to rely on a Medicare-covered diagnostic sleep test with qualifying values (as described in the Coverage Indications, Limitations, and/or Medical Necessity section above) that is eligible for coverage and reimbursement by the A/B MAC contractor. No changes to any additional oral appliance device coverage criteria were made as a result of this reconsideration.

Coding Information

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service

GA - Waiver of liability statement issued, as required by payer policy

GZ - Item or service expected to be denied as not reasonable and necessary

KX -Requirements specified in the medical policy have been met

HCPCS CODES:

Group 1 Codes
CodeDescription
A9270 NON-COVERED ITEM OR SERVICE
E0485 ORAL DEVICE/APPLIANCE USED TO REDUCE UPPER AIRWAY COLLAPSIBILITY, ADJUSTABLE OR NON-ADJUSTABLE, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT
E0486 ORAL DEVICE/APPLIANCE USED TO REDUCE UPPER AIRWAY COLLAPSIBILITY, ADJUSTABLE OR NON-ADJUSTABLE, CUSTOM FABRICATED, INCLUDES FITTING AND ADJUSTMENT
E1399 DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS

General Information

Associated Information

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

  • SWO
  • Medical Record Information (including continued need/use if applicable)
  • Correct Coding
  • Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

MISCELLANEOUS

APPENDICES

EPWORTH SLEEPINESS SCALE

How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? This refers to your usual way of life in recent times. Even if you have not done some of these things recently try to work out how they would have affected you.

Use the following scale to choose the most appropriate number for each situation:

0 = would never doze or sleep

1 = slight chance of dozing or sleeping

2 = moderate chance of dozing or sleeping

3 = high chance of dozing or sleeping

Situation

Chance of Dozing or Sleeping

Sitting and reading

____

Watching TV

____

Sitting inactive in a public place

____

Being a passenger in a motor vehicle for an hour or more

____

Lying down in the afternoon

____

Sitting and talking to someone

____

Sitting quietly after lunch (no alcohol)

____

Stopped for a few minutes in traffic while driving

____

Total score (add the scores up)

(This is your Epworth score)

____

 

0-9 - Average score, normal population

Epworth Sleepiness Scale reprinted with permission of the Associated Professional Sleep Societies (Johns MW; A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale. SLEEP 1991;14(6):540-545).

UTILIZATION GUIDELINES

Refer to Coverage Indications, Limitations and/or Medical Necessity

Sources of Information
N/A
Bibliography

NA

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
08/08/2021 R7

Revision Effective Date: 08/08/2021
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: “face-to-face” to “in-person” 
Removed: Not reasonable and necessary denial statement regarding custom fabricated mandibular advancement devices that do not receive written coding verification
Revised: Sleep Tests section to point to NCD 240.4.1 and applicable A/B MAC LCDs and Billing and Coding articles
SUMMARY OF EVIDENCE:
Added: Information related to diagnostic sleep testing
ANALYSIS OF EVIDENCE:
Added: Information related to diagnostic sleep testing
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A58823)

  • Provider Education/Guidance
  • Reconsideration Request
01/01/2020 R6

Revision Effective Date: 01/01/2020
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”


As required by CR 10901, the ICD-10 information has been moved to all Policy Articles. There is no change in coverage.

  • Other
01/01/2020 R5

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: “physician” to “treating practitioner”
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 code list in the LCD-related Policy Article
GENERAL:
Revised: Order information as a result of Final Rule 1713
DOCUMENTATION REQUIREMENTS:
Revised: “physician’s” to “treating practitioner’s”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: “Prescriptions (orders)” to “SWO”

02/13/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713.

  • Provider Education/Guidance
01/01/2019 R4

Revision Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Statement to refer to diagnosis code section below
Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: Diagnosis code to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statement about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

  • Other (ICD-10 code relocation per CMS instruction)
01/01/2017 R3 Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Supplier manual reference from Miscellaneous
Removed: PIM reference under Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
07/01/2016 R2 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
10/01/2015 R1 Revision Effective Date: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Added: Continued Medical Need/ Continued Use sections
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for equipment retained from a prior payer
Added: Repair/Replacement section
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Diagnosis code reference
  • Provider Education/Guidance

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
06/18/2021 08/08/2021 - N/A Currently in Effect You are here
02/13/2020 01/01/2020 - 08/07/2021 Superseded View
02/07/2020 01/01/2020 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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