Proposed Local Coverage Determinations (LCDs) Released for Comment – Nebulizers and Urological Supplies - JD DME
Proposed Local Coverage Determinations (LCDs) Released for Comment - Nebulizers and Urological Supplies
Joint DME MAC Publication
Posted August 28, 2025
The Centers for Medicare and Medicaid Services (CMS) assigned to the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) the task of developing LCDs for Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS). The DME MACs are proposing two LCDs as described below:
Nebulizers (DL33370) – Proposing a reasonable and necessary determination for the use of ensifentrine (J7601), for the management of chronic obstructive pulmonary disease in patients with continued exacerbations or persistent dyspnea while on maintenance therapy with a long-acting beta-agonist (LABA) and a long-acting muscarinic-agonist (LAMA) with or without an inhaled corticosteroid based on the best available evidence; and, proposing a reasonable and necessary determination for the use of hypertonic saline (J7131) for the management of cystic fibrosis, non-cystic fibrosis bronchiectasis and primary ciliary dyskinesia based upon the best available evidence.
Urological Supplies (DL33803) – Proposing inclusion of an example in the coverage criteria for sterile intermittent urinary catheter kits and supplies (A4297, A4353) for Medicare beneficiaries with a spinal cord injury; and, proposing addition of new HCPCS codes (A4295, A4296, A4297) for hydrophilic catheters.
Stakeholders may read the details of each proposed LCD posted on the Medicare Coverage Database by referencing the LCD ID number in the search field. The entire proposed LCD(s) should be reviewed prior to the submission of written comments.
We are soliciting comments on the proposed LCDs from stakeholders (including, but not limited to, clinicians, manufacturers, suppliers, and other parties who care for Medicare beneficiaries). You should be very specific in your comments and, if possible, offer suggestions that may address your concerns. You should provide an evidence-based rationale for your comments and attach any full-text references from the published clinical literature (for example, peer-reviewed journals, clinical society guidelines, etc.) that were not included in the bibliography of the proposed LCD. We encourage a written response regardless of your agreement or disagreement with the proposed LCD.
In your comments, please be sure to disclose all conflicts of interest you have with any manufacturer(s) or supplier(s) of the DMEPOS items addressed in the proposed LCD.
All comments will be collected at a single point of contact for each proposed LCD. Comments that address more than one proposed LCD must be submitted to each LCD email address for which comments are being made. Do not include any protected health information (PHI) or personally identifiable information (PII). Submit your comments electronically to the DME MACs at the applicable email address(es) listed below no later than Saturday, October 11, 2025.
Nebulizers (DL33370): NEBRecon@noridian.com
Urological Supplies (DL33803): URORecon@noridian.com
If the proposed LCD coverage criteria refer to an LCD-related Policy Article (PA), then a convenience copy of a draft PA document may be attached to the proposed LCD. A draft PA document attached to a proposed LCD is only provided for reference purposes.
Suppliers and clinicians are cautioned not to make any changes based upon information contained in a proposed LCD. The content of a proposed LCD may be revised based upon the written comments received during the comment period. When all written comments have been reviewed, revisions will be considered.
IMPORTANT: The DME MACs will host virtual open meetings to further solicit input from stakeholders for the proposed LCDs. The virtual meetings will take place on October 2, 2025. For details regarding participation in the virtual open meetings, refer to the open meeting announcement articles posted at Open Meeting Announcement – Nebulizers Proposed Local Coverage Determination (LCD) and Open Meeting Announcement – Urological Supplies Proposed Local Coverage Determination (LCD).
Refer to each DME MAC website for additional information, including access to the proposed LCDs.
Thank you for your participation in our policy development process.
Smitha M. Ballyamanda, MD, CAQSM
Medical Director, DME MAC Jurisdiction A
Noridian Healthcare Solutions, LLC
Sunil V. Lalla, MD, FACS, CPC
Medical Director, DME MAC Jurisdiction B
CGS Administrators, LLC
Robert D. Hoover, Jr., MD, MPH, FACP
Medical Director, DME MAC Jurisdiction C
CGS Administrators, LLC
Angela S. Jenny, DO, DABFM
Medical Director, DME MAC, Jurisdiction D
Noridian Healthcare Solutions, LLC
