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September 30, 2021

Proposed Local Coverage Determinations (LCDs) Released for Comment – Nebulizers and Pneumatic Compression Devices

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:

  1. Nebulizers (DL33370) – Proposing extension of treprostinil inhalation solution coverage, to treatment of pulmonary hypertension associated with interstitial lung disease; removal of treprostinil inhalation solution and iloprost coverage from treatment of chronic thromboembolic pulmonary hypertension
  2. Pneumatic Compression Devices (DL33829) – Proposing that arterial intermittent pneumatic compression treatment for inoperable chronic limb ischemia remain as "not reasonable and necessary"

Stakeholders may read the details of the proposed LCDs posted on the Medicare Coverage Database by referencing the LCD ID number in the search field. The entire proposed LCD should be reviewed prior to the submission of written comments.

We are soliciting comments on these 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 LCDs. We encourage a written response regardless of your agreement or disagreement with the proposed LCDs.

All comments will be collected at a single point of contact for each proposed LCD. Comments that address more than one proposed LCD should 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). Please submit your comments electronically to the DME MACs at the email addresses below no later than Saturday, November 13, 2021 at 5 pm ET.

Nebulizers (DL33370):

Pneumatic Compression Devices (DL33829):

Suppliers and clinicians are cautioned not to make any changes based upon information contained in a proposed LCD, as the revisions posed in a proposed LCD may be further revised or otherwise updated based upon the comments received. When all comments have been reviewed, revisions will be considered.

*IMPORTANT: The DME MACs will host virtual open meetings to further solicit input from stakeholders for each of the proposed LCDs. These virtual meetings will take place on November 3, 2021. 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 – Pneumatic Compression Devices 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
Robert D. Hoover, Jr., MD, MPH, FACP
Medical Director, DME MAC Jurisdiction C
CGS Administrators, LLC
Stacey V. Brennan, MD, FAAFP
Medical Director, DME MAC Jurisdiction B
CGS Administrators, LLC
Peter J. Gurk, MD, CPE, CHCQM
Medical Director, DME MAC, Jurisdiction D
Noridian Healthcare Solutions, LLC


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