LCD Reference Article Response To Comments Article

Response to Comments: Oral Appliances for Obstructive Sleep Apnea – DL33611

A58823

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Article ID
A58823
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Article Title
Response to Comments: Oral Appliances for Obstructive Sleep Apnea – DL33611
Article Type
Response to Comments
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06/24/2021
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During the 45-day comment period, which was open February 25, 2021 through April 10, 2021, the DME MACs received comments from 5 different commenters.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period on the proposed Oral Appliances for Obstructive Sleep Apnea Local Coverage Determination (LCD) (DL33611). We reviewed the comments in their entirety. Submitted comments that cite published, peer-reviewed literature provide suitable evidence that may inform policy, while less rigorous comments (e.g., anecdotal, unpublished information not subject to peer review) are much less influential to policy determinations.

NOTE: DME MACs review all submitted comments and may choose to consolidate similar thematic comments or redact or withhold certain submissions (or portions thereof such as those containing private or proprietary information or inappropriate language, language or duplicate/near duplicate submissions). As a result, there may be a discrepancy between the number of comments in the article and the actual number of comments received.

Response To Comments

Number Comment Response
1

Two commenters had concerns about the absence of the home sleep apnea test requirements in the proposed Oral Appliances for Obstructive Sleep Apnea LCD. The commenters were concerned that removal of this information (which is not included in the National Coverage Determination 240.4.1) could negatively impact the quality of care provided to patients with obstructive sleep apnea through de-emphasizing patient education, proper training and credentialing for clinicians, and accreditation requirements.

The DME MACs appreciate the advocacy of these commenters on behalf of Medicare beneficiaries. 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 this LCD. The DME MACs have confirmed that all A/B MAC LCDs and/or Billing and Coding articles for polysomnography address the patient education, credentialing, and accreditation concerns expressed in the comments. Please refer to the applicable A/B MAC LCDs and Billing and Coding articles for additional details regarding coverage and payment rules for sleep tests. In addition, at least one sleep lab accreditation entity includes a patient education standard as part of their accreditation process required by the A/B MAC LCDs.

2

One commenter identified that the new version removes the wording of face-to-face demonstrations in the section on sleep testing and requested clarification on requirements of face-to-face versus telehealth encounters.

The revised wording from “face-to-face” to “in-person” was simply to reflect preferred wording for interactions with patients that are not “virtual.” This revision does not impact the ability to interact with patients using CMS-approved methods of telehealth.

3

One commenter requested clarification regarding the PDAC review requirements for an item to be coded using E0486. The commenter noted, in current form, both the LCD and the LCD-related Policy Article mention requirements for PDAC review in order for an item to be coded using E0486.

Thank you for the comment; however, this is outside the scope of this LCD reconsideration. Stakeholders should be aware that the DME MACs retained the definition of an oral appliance and the requirement for PDAC review of devices coded E0486 in the LCD-related Policy Article (A52512). Custom fabricated oral appliances coded E0486 fall under the Durable Medical Equipment (DME) benefit. The PDAC review of devices coded E0486 is necessary to confirm that the oral appliances included in code E0486 meet the requirements for classification as DME.

4

One commenter stated that though it is not within a dentist’s scope of practice to diagnose obstructive sleep apnea, the American Dental Association, American Association of Orthodontics, and the AADSM all support dentists using a comprehensive medical and dental history and clinical examination to screen for OSA. They added that currently 44 states do not prohibit dentists from ordering obstructive sleep apnea testing.

Thank you for the comment; however, this is outside the scope of this LCD reconsideration.

5

One commenter suggested that the DME MACs specify in criterion D of the LCD (The device is provided and billed for by a licensed dentist (DDS or DMD)) that provision of a custom fabricated oral appliance must require a face-to-face encounter.

Thank you for the comment; however, the request is outside the scope of this LCD reconsideration.

6

One commenter suggested that the DME MACs specify that in-person evaluation requirements can be waived in circumstances when telehealth encounters are allowed.

The revised wording from “face-to-face” to “in-person” was simply to reflect preferred wording for interactions with patients that are not “virtual.” This revision does not impact the ability to interact with patients using CMS-approved methods of telehealth.

7

One commenter suggested that Policy Article (A52512) be further modified to remove the language that prohibits dentists from ordering or delivering home sleep apnea tests.

Thank you for the comment; however, the request is to revise the policy article which is outside the scope of this LCD reconsideration.

8

One commenter suggested that the coding guidelines in the Policy Article (A52512) be clarified for a custom fabricated mandibular advancement device to reflect current oral appliance technology and account for beneficiaries who may suffer from metal hypersensitivity.

Thank you for the comment; however, the request is to revise the policy article which is outside the scope of this LCD reconsideration. Stakeholders should be aware that custom fabricated oral appliances coded E0486 fall under the Durable Medical Equipment (DME) benefit. To be considered a Medicare-covered oral appliance, the requirements of the DME benefit must be met. See the LCD-related Policy Article (A52512).

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L33611 - Oral Appliances for Obstructive Sleep Apnea
Related National Coverage Documents
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Updated On Effective Dates Status
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