Open Meeting Notification - Proposed LCD(s) Released for Comment
Part B LCD
1. Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depressive Disorder DL34869
A/B MAC LCDs
1. Cervical Disc Replacement DL38033
2. Corneal Hysteresis DL38026
1. Lab: Drug Interaction Testing DL38037
2. MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease DL38035
3. MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Unfavorable Intermediate Risk Disease DL38029
4. MolDX: Guardant360® Plasma-Based Comprehensive Genomic Profiling in Solid Tumors DL38043
5. MolDX: Next-Generation Sequencing for Solid Tumors DL38045
6. MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies DL38047
7. MolDX: Pigmented Lesion Assay DL38051
8. MolDX: Prospera DL38041
9. MolDX: TruGraf Blood Gene Expression Test DL38039
The Centers for Medicare & Medicaid Services (CMS) assigned Palmetto GBA the task of developing local coverage determinations (LCDs) for processing and reviewing Medicare claims for Jurisdictions J. These LCDs can be found on the JJ Proposed LCDs Status Report located on the Medicare Coverage Database. The entire LCD and related article(s) should be completely reviewed prior to the preparation of comments.
Palmetto GBA is soliciting comments on these proposed LCDs from physicians, manufacturers, suppliers and other professionals involved in the ordering and/or provisioning of these items. Other stakeholder comments are also welcomed. For medical professionals, we ask that you distribute these proposed LCDs to selected members of your organization for review and comment. If you disagree with any aspect of an LCD, you should be very specific in your comment and, if possible, offer an alternative. You should provide a clinical rationale for your position, including references from published clinical literature (e.g., peer-reviewed journals, clinical society guidelines, etc.). Submission of full-text literature supporting your position is strongly encouraged. We ask for a written response, regardless of your agreement or disagreement.
Please submit your comments and signed consent form electronically to Palmetto GBA at A.Policy@palmettogba.com, B.Policy@palmettogba.com or MolDX.Policy@palmettogba.com no later than 4/12/19.
An open meeting will be held in-person in South Carolina. This meeting will be recorded live and will be published on the Palmetto GBA website. Interested parties from within the jurisdiction may attend this open meeting. This meeting is for oral presentations only. Palmetto GBA requires all presenters at the open meeting to also submit their oral comments through the formal comment process.
Conference Title: Palmetto GBA Open Meeting
Conference Date: 5/6/19
Conference Time: Jurisdiction J (JJ) 2:30 – 4:30 p.m. ET
Conference Location: Blue Cross Blue Shield, Tower Auditorium, 2501 Faraway Drive, Columbia, SC 29223
Conference Dial-In Number: 877-375-2583
Advance registration is required. Registration is online and must be completed prior to 4/15/19. If you do not register to attend, you will be turned away if the meeting space is at capacity. You may register by logging onto the Event Registration Portal and selecting the event you wish to attend. New users must create a profile before registering for the event. To create a user profile, select the Create Profile link under the Login button on the blue menu bar and follow the instructions. You will receive your profile login information via email once you complete registration. Palmetto GBA reserves the right to limit the time for oral comments as determined by the number LCDs to be discussed and the number of presenter registrants.
Note: You may enter "n/a" if you do not have an NPI or PTAN when creating a User Profile when registering for the event.
Presenters should adhere to the following:
Submit a copy of your presentation to A.Policy@palmettogba.com, B.Policy@palmettogba.com or MolDX.Policy@palmettogba.com prior to 4/12/19 (required).
Bring a laptop or tablet that contains a VGA interface for connecting to a projector. Your device should have a 15 pin VGA female output. If your device has a different output, please bring an adapter ready to plug into a 15 pin male VGA (required).
Provide copies of the presentation (optional).
An agenda will be published two weeks prior to the open meeting.
Important reminder: Providers and/or suppliers are cautioned not to make any changes based upon the information contained in a proposed LCD. Proposed LCDs are often substantially revised based upon the comments received. Revisions will be considered once all comments have been reviewed. The final LCD will be published in the CMS Medicare Coverage Database and on individual contractors’ websites, allowing for a minimum of 45-days public notice before the LCD becomes effective.
Refer to each contractor’s web site for additional information about LCD development and for copies of the draft LCDs.