Nebulizers Open Meeting - October 2, 2025 - JA DME

MICHAEL HANNA (00:00:01)
Hello, everyone, and welcome to the LCD Opening Meeting for Nebulizers. At present, there have been no stakeholders requested to speak on the meeting so, I will now turn it over to Dr. Robert Hoover who will discuss the updates or proposed changes to the Nebulizers webinar LCD.

DR. ROBERT HOOVER (00:00:21)
Thank you, Michael, and good morning, everyone, and welcome to our virtual open meeting.

Today, we'll be soliciting public comments regarding the proposed Nebulizers Local Coverage Determination.

My name is Dr. Robert Hoover, and I'm with CGS Administrators, the Jurisdiction C, DME MAC.

Today, I'm joined by Drs. Angela Jenny and Smith Ballya- Ballyamanda, representing Noridian Healthcare Solutions, the Jurisdictions A and D, DME MAC, and Dr. Sunil Lalla, the Jurisdiction B DME Medical Director with CGS.

We look forward to your comments regarding the proposed Nebulizers LCD update. Please send your comments to us via email, which is preferred, at NEBRecon@noridian.com. That's N-E-B Recon@noridian.com. These comments are due by 5 p.m. Eastern Time on Saturday, October the 11th, 2025, after which time the comment period closes.

Also, we are recording the meeting today, and a copy of this meeting will be posted on the DME MAC websites in the coming weeks.

We had no registered commenters to speak at today's meeting, but anyone could submit written comments to the email address I mentioned earlier. Please remember that we only respond to written comments.

Now I'll move to an overview of the proposed changes in the LCD.

The proposed LCD adds a reasonable and necessary determination for the use of ensifentrine, HCPCS code J7601, also called Ohtuvayre. Ohtuvayre is FDA-indicated for the management of chronic pulmonary, obstructive pulmonary disease in patients with continued exacerbations, or persistent dyspnea while on maintenance therapy with a long-acting beta agonist, or LABA, and a long-acting muscarinic agent, or LAMA, with or without an inhaled corticosteroid.

The proposed LCD also incorporates a reasonable and necessary determination for the use of hypertonic saline, HCPCS code J7131, for the management of cystic fibrosis, non-cystic fibrosis bronchiectasis, and primary ciliary dyskinesia, based on the best possible evidence.

Since there were no public speakers for today's meeting, we'll wrap up the meeting for today. Thank you for attendance, and look forward to your written comments. Once again, please remember to send your comments in writing to NEBRecon@noridian.com by the deadline date of 5 p.m. Eastern Time on Saturday, October the 11th, 2025.

Once we have considered and correlated all of the comments received during the open comment period, we'll consider any changes necessary as a result of the comments received, and then post a final LCD along with a response to comments document. The final LCD will take effect a minimum of 45 days following the posting of the final LCD.

For any updates, please refer to the DME MAC websites.

On behalf of my medical director colleagues and the DME MAC staff at Noridian and CGS, I want to thank everyone for participating today.

We will formally adjourn this meeting now.