Local Coverage Article Response to Comments

Response to Comments: Nebulizers – DL33370


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Article ID
Article Title
Response to Comments: Nebulizers – DL33370
Article Type
Response to Comments
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During the 45-day comment period, which was open from September 30, 2021 through November 13, 2021, the DME MACs received comments from four commenters.

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 stakeholders 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.

Response To Comments


One commenter expressed their support for the proposed coverage criteria of treprostinil for beneficiaries with pulmonary hypertension (PH) due to interstitial lung disease (ILD; PH-ILD).

The DME MAC Medical Directors thank the commenter for the feedback. The coverage criteria for treprostinil used in the treatment of PH-ILD will be finalized as proposed. 


One commenter requested the addition of ICD-10-CM code J84.9 (interstitial pulmonary disease) to the policy article indicating that ILD encompasses over 100 lung disorders that inflame or scar the lungs and clinicians may not be able to code to the level of specificity required. 

The final policy article will remain as proposed. Clinicians are encouraged to code to the highest degree of specificity with ICD-10 and avoid the use of a not otherwise classified (NOC) code where feasible. ICD-10 code J84.9 (interstitial pulmonary disease) is a NOC code which may potentially create unintended coverage unrelated to PH-ILD.


One commenter expressed concerns regarding coverage of treprostinil for beneficiaries that meet coverage criteria and have a qualifying pulmonary arterial hypertension (PAH) diagnosis in addition to a diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH). 

Beneficiaries who otherwise meet coverage criteria and have a qualifying diagnosis of PAH would not be denied for the addition of a CTEPH diagnosis on the claim.  


Two commenters indicated that removal of coverage of treprostinil and iloprost for individuals with a diagnosis of PAH secondary to CTEPH (WHO Group 4) will negatively impact a small number of beneficiaries currently receiving and benefiting from this therapy. One of those commenters indicated that even a brief disruption in treatment increases the likelihood of adverse events, such as hospitalization and death. The commenter referenced a few small clinical trials and a case report supporting the use of treprostinil and iloprost in this population. 

As indicated in the proposed Nebulizers LCD (DL33370), neither iloprost nor treprostinil inhalation solution has an FDA approved indication for CTEPH (WHO Group 4). The CMS Benefit Policy Manual (100-02), section 50.4.2 outlines the situations in which the MACs may cover drugs for off label indications. In relevant part, the MACs may cover the off-label indication if the MAC “determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.” The DME MACs reviewed the literature cited by the commenter. Additionally, the DME MACs conducted a review of FDA indications, Lexicomp off-label use and a literature review for iloprost and inhaled treprostinil-label indications for use in patients with CTEPH (WHO Group 4) in the outpatient setting. Therefore, after a thorough review of the available evidence, the Nebulizer LCD and Policy Article will remain as proposed. 

Associated Documents

Related Local Coverage Documents
L33370 - Nebulizers
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
04/14/2022 04/21/2022 - N/A Currently in Effect You are here