Local Coverage Article Response to Comments

Response to Comments: Respiratory Assist Devices - DL33800


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Article ID
Article Title
Response to Comments: Respiratory Assist Devices - DL33800
Article Type
Response to Comments
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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 2 commenters.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period on the proposed Respiratory Assist Devices Local Coverage Determination (LCD) (DL33800). 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literature provide suitable evidence that may inform policy, while less rigorous comments (e.g., anecdotal, unpublished information not subject to peer review) are much less influential to policy determinations.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 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


Commenters had concerns about the absence of the home sleep apnea test requirements in the proposed Respiratory Assist Devices 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 the Respiratory Assist Devices LCD (DL33800). 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.

Associated Documents

Related Local Coverage Documents
L33800 - Respiratory Assist Devices
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
06/18/2021 06/24/2021 - N/A Currently in Effect You are here


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