Tumor Treatment Field Therapy (DL34823) Proposed LCD 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 a revision to the Tumor Treatment Field Therapy (TTFT LCD L34823) to cover newly diagnosed glioblastoma multiforme (GBM).

The proposed policy extends coverage for use of TTFT as a treatment option for Medicare beneficiaries with newly diagnosed GBM when certain coverage criteria are met. Stakeholders may read the details of the proposed TTFT LCD posted on the Medicare Coverage Database (Reference DME MAC DL34823).  The entire LCD should be completely reviewed prior to the submission of written comments.

We are soliciting comments on this proposed LCD from clinicians, manufacturers, suppliers, and other stakeholders who care for or may provide these items to Medicare beneficiaries with newly diagnosed GBM. 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 LCD. We encourage a written response regardless of your agreement or disagreement with this proposed LCD.  

All comments will be collected at a single point of contact. Please submit your comments electronically to the DME MACs at the e-mail address below no later than Monday, June 24, 2019 at 5 p.m. EDT. TTFTLCDComments@cgsadmin.com

To further solicit input on this proposed LCD, the DME MACs will be hosting a public meeting on June 20, 2019 from 9 a.m. until noon EDT at the Westin Baltimore Washington International Airport (1110 Old Elkridge Landing Rd, Linthicum Heights, MD 21090). 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, either in-person or via telephone, must register in advance by Friday, June 14, 2019 at 5 p.m. EDT. Registration is online here. 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: 570-597-974

*Note: a separate PIN will be provided at the time of registration 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 LCD. 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 the final LCD. The final LCD 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 LCD is effective.

Refer to each DME MAC web site for additional information about policy development and copies of the proposed LCD.

Jurisdiction A – https://med.noridianmedicare.com/web/jadme
Jurisdiction B – https://www.cgsmedicare.com/jb/index.html
Jurisdiction C – https://www.cgsmedicare.com/jc/index.html
Jurisdiction D – https://med.noridianmedicare.com/web/jddme

Thank you for your participation in our policy revision process.

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

On behalf of:
Wilfred Mamuya, MD, PhD
Medical Director, DME MAC, Jurisdiction A
Noridian Healthcare Solutions

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

 

Last Updated May 09, 2019