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December 26, 2019

Open Meeting Announcement – Oxygen & Oxygen Equipment (DL33797), Nebulizers (DL33370) and External Infusion Pumps (DL33794)

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 the following LCDs:

Oxygen & Oxygen Equipment (L33797) – Topical oxygen therapy reconsideration request

Nebulizers (L33370) – Proposed coverage for Yupelri® (Revefenacin)

External Infusion Pumps (L33794) – Proposed coverage for Xembify® (immune globulin subcutaneous, human – klhw) 20% Solution

Stakeholders may read the details of the proposed LCDs posted on the Medicare Coverage Database. The entire proposed LCD should be completely reviewed prior to the preparation of submitting comments.

We are soliciting comments on each proposed LCD from clinicians, manufacturers, suppliers and other professionals involved in the ordering or provision of these items. Other stakeholder comments are also welcome. For medical professionals, we ask that you distribute the proposed LCDs to selected members of your organization for review and comment. If you disagree with any aspect of a proposed LCD, you should be very specific in your comment 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 the proposed LCDs.

Comments for the individual proposed LCDs will be collected at a single point of contact. Please submit your comments electronically to the DME MACs at the e-mail addresses below no later than February 10, 2020 at 5:00 PM EST/4:00 PM CST.

Oxygen & Oxygen Equipment LCD – TOTRecon@noridian.com
Nebulizer LCD – NEBLCDComments@cgsadmin.com
External Infusion Pumps LCD – EIPRecon@noridian.com

To further solicit input on these proposed LCDs, the DME MACs will be hosting a public meeting on Tuesday, January 28, 2020 starting at 10:00 AM EST/ 9:00 AM CST at the Hyatt Regency DFW, 2334 N International Pkwy, Dallas, TX 75261. This meeting is for oral presentation of comments and for those stakeholders interested in listening to the comments.

Due to scheduling and time limitations, organizations wishing to have multiple commenters are requested to combine remarks and have one appointed speaker.

In order for oral comments to be considered, they must be presented in writing through the formal comment process. Stakeholders interested in attending the meeting and commenting, either in-person or via telephone, must register in advance by Friday, January 17, 2020 at 5:00 PM EST/4:00 PM CST. Registration is available online through Cvent hereExternal Website.

Any material (e.g., handouts, slides) that a registrant will present during the open meeting must also be sent to OpenMeeting@noridian.comExternal Website by Friday, January 17, 2020 at 5:00 PM EST/4:00 PM CST. 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: (888) 313-0470
Access Code: 228 655 597#

*Note: a separate email will be sent prior to the meeting to participants who wish to provide oral comments.

Presentation time limitations for oral commenters will be determined based on the number of commenters registered. Speaking time and order of commenters will be available at the meeting site.

*IMPORTANT REMINDER* Suppliers and clinicians are cautioned not to make any changes based upon the information contained in the proposed LCDs. Proposed LCDs are sometimes 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 each final LCD. The final LCDs will be published in the CMS Medicare Coverage Database and 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 about policy development and copies of each proposed LCD.

Thank you for your participation in our policy revision process.

Sincerely,

Wilfred Mamuya, MD, PhD.
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
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