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December 17, 2020

Open Meeting Announcement – Glucose Monitors and External Infusion Pumps Local Coverage Determinations - Proposed LCDs Released for Comment

The Centers for Medicare and Medicaid Services (CMS) assigned to the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) the task of developing Local Coverage Determinations (LCDs) for Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS). The DME MACs are proposing revisions to two LCDs as described below:

Glucose Monitors LCD (DL33822) - Modify the coverage criteria for continuous glucose monitors. The changes proposed include:
- Removing Criterion 2 that requires that the beneficiary has been using a BGM (blood glucose monitor) and performing frequent (four or more times a day) testing; and,
- Modifying Criterion 3 to accommodate the use of inhaled insulin to meet the multiple daily administrations of insulin.
External Infusion Pumps LCD (DL33794) – Modify criteria for Hizentra^® to consider coverage for chronic inflammatory demyelinating polyneuropathy (CIDP).

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 completely reviewed prior to the submission of written comments.

We are soliciting comments on these proposed LCDs from clinicians, manufacturers, suppliers, and other stakeholders 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 (e.g. 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 these proposed LCDs.

All comments will be collected at a single point of contact for each proposed LCD. Please submit your comments electronically to the DME MACs at the e-mail addresses below no later than Saturday January 30, 2021 at 5 PM EST.

Glucose Monitors LCD (DL33822): BGMLCDComments@cgsadmin.com

External Infusion Pumps LCD (DL33794): EIPRecon@noridian.com

To further solicit input on these proposed LCDs, the DME MACs will be hosting a virtual public meeting on Tuesday, January 19, 2021 from 11 AM until 12:30 PM EST.

This meeting is for oral presentation of comments and for those stakeholders interested in listening to the comments. In order for any oral comments to be considered, they must be presented in writing through the formal comment process. Stakeholders interested in attending the meeting and commenting, must register in advance by January 15, 2021 at 5:00 PM EST. Registration is online here.

Any material (e.g., handouts, slides) that a registrant will present during the open meeting must be sent to OpenMeetings@cgsadmin.com by January 15, 2021 at 5:00 PM EST. In the body of the email, please include the name of the presenter and the represented organization (if applicable). By registering you consent to your comments being recorded at the meeting.

Advance registration is not required for those stakeholders who only wish to listen to the open meeting. To access the meeting via teleconference, please use the following information:

Conference dial-in number:
US Toll free: 1 (877) 309-2071
Access Code: 846-470-307

*Note: A telephone audio PIN will be provided, to participants who wish to make oral comments after joining the webinar.

The amount of time allotted for oral commenters’ presentations will be determined based on the number of commenters registered. Speaking time and order of commenters will be available at the time of the virtual meeting.

*IMPORTANT REMINDER* Suppliers and clinicians are cautioned not to make any changes based upon the information contained in the proposed LCDs. Proposed LCDs may be revised based upon the comments received. When all comments have been reviewed, revisions will be considered. A Response to Comments document will be published with the final LCDs. The final LCDs will be published in the CMS Medicare Coverage Database and accessible on individual DME MAC websites, allowing for a 45-day notice period before the final LCDs are effective.

Refer to each DME MAC web site for additional information, including access to the proposed LCDs.

Thank you for your participation in our policy development process.

Sincerely,
Robert D. Hoover, Jr., MD, MPH, FACP

On behalf of:

Smitha M. Ballyamanda, MD, CAQSM Medical Director, DME MAC Jurisdiction A Noridian Healthcare Solutions, LLC	Stacey V. Brennan, MD, FAAFP 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	Peter J. Gurk, MD, CPE, CHCQM Medical Director, DME MAC, Jurisdiction D Noridian Healthcare Solutions, LLC

License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

AMA Disclaimer of Warranties and Liabilities.

CMS Disclaimer

POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

Open Meeting Announcement – Glucose Monitors and External Infusion Pumps Local Coverage Determinations - Proposed LCDs Released for Comment

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