LCD Reference Article Response To Comments Article

Response to Comments: Nebulizers – DL33370

A60378

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Source Article ID
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Article ID
A60378
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Nebulizers – DL33370
Article Type
Response to Comments
Original Effective Date
12/18/2025
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During the 45-day comment period, which was open from August 28, 2025 through October 11, 2025, the DME MACs received comments from 1 commenter.

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, 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.

Introduction to Responses

The DME MACs appreciate the comments received from the stakeholder during the open comment period for the proposed Nebulizers Local Coverage Determination (LCD) (DL33370).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support optimal health outcomes in Medicare beneficiaries.

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13.5.5:

MACs are required to provide a minimum of 45 calendar days for public comment on all proposed LCDs. MACs shall respond to all timely received public comments, and may group similar comments and responses in logical categories in the RTC article.

Accordingly, comments regarding the associated Policy Article, while noted, will not be addressed in the RTC article.

Response To Comments

Number Comment Response
1

A commenter requested clarification regarding the management of Medicare beneficiaries who have already been established on ensifentrine prior to the finalization of the LCD.

Claims for ensifentrine will be denied for beneficiaries who do not meet the coverage criteria in the final LCD; however, a claim may be considered for coverage through the appeals process.

2

A commenter inquired whether beneficiaries are required to continuously adhere to a standard of care maintenance regimen while receiving ensifentrine, or if a previously unsuccessful attempt with standard dual or triple therapy maintenance is adequate to satisfy the coverage requirements.

The beneficiary must use either long-acting beta-agonist (LABA) + long-acting muscarinic-agonist (LAMA) dual therapy or LABA+LAMA+inhaled corticosteroid (ICS) triple therapy to meet the coverage criteria. Ensifentrine use without these therapies is not considered reasonable or necessary. The final LCD will be edited to clarify that coverage of ensifentrine is limited to use as add-on therapy as part of a standard of care maintenance regimen.

3

A commenter requested clarification regarding the documentation requirements outlined in the Policy Article (A52466).

Thank you for your comment. We will take the request for clarification of the Policy Article language into consideration; however, comments concerning the associated Policy Article, while noted, are not addressed in the RTC article.

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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
L33370 - Nebulizers
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Updated On Effective Dates Status
12/11/2025 12/18/2025 - N/A Currently in Effect You are here

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