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May 25, 2023

Proposed Local Coverage Determination (LCD) Released for Comment – External Upper Limb Tremor Stimulator Therapy

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 an LCD as described below:

External Upper Limb Tremor Stimulator Therapy (DL39591) – Proposing a not reasonable and necessary determination for external upper limb tremor stimulator therapy and related supplies and accessories based on the best available evidence.

Stakeholders may read the details of the proposed LCD 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 the proposed LCD 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 the proposed LCD. 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 listed below no later than Saturday, July 8, 2023.

External Upper Limb Tremor Stimulator Therapy (DL39591):

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 a virtual open meeting to further solicit input from stakeholders for the proposed LCD. The virtual meeting will take place on June 27, 2023.For details regarding participation in the virtual open meeting, refer to the open meeting announcement article posted at Open Meeting Announcement – External Upper Limb Tremor Stimulator Therapy Proposed Local Coverage Determination (LCD).

Refer to each DME MAC website for additional information, including access to the proposed LCD.

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
Sunil V. Lalla, MD, FACS, CPC
Medical Director, DME MAC Jurisdiction B
CGS Administrators, LLC
Angela S. Jenny, DO
Medical Director, DME MAC, Jurisdiction D
Noridian Healthcare Solutions, LLC


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