Local Coverage Article Response to Comments

Response to Comments: Nebulizers - DL33370


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Response to Comments: Nebulizers - DL33370
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Response to Comments
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During the 45-day comment period the DME MACs received a total of 2 comments.

Introduction to Responses

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

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 with a diagnosis of chronic obstructive pulmonary disease (COPD).

Response To Comments


Two commenters suggested that the Proposed LCD language be clarified to indicate that a short-acting muscarinic antagonist will be denied as not reasonable and necessary when used with a long-acting muscarinic antagonist. The commenters indicated the current language did not specify which drug would be reasonable and necessary when both are billed concurrently.

The DME MACs appreciate the comments and agree. For clarity, the final LCD has been updated to include the following language:

Revefenacin (J7677) is a long-acting muscarinic antagonist. Concurrent use of long-acting and short-acting muscarinic antagonists, such as ipratropium (J7644) is not reasonable and necessary. Therefore, if a long-acting muscarinic antagonist is used, the short-acting muscarinic antagonist will be denied as not reasonable and necessary.

Associated Documents

Related Local Coverage Documents
L33370 - Nebulizers
Related National Coverage Documents
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Updated On Effective Dates Status
03/26/2020 04/02/2020 - N/A Currently in Effect You are here