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Jurisdiction J Open Meeting Notification — Proposed LCD(s) Released for Comment
10/07/2019 JJ Part A
JJ Part B
02:30 PM - 04:30 PM Open Meeting
Blue Cross Blue Shield, Tower Auditorium
2501 Faraway Drive
Columbia, SC 29223

Part B LCD

1. Varicose Veins of the Lower Extremities DL33454

 

A/B MAC LCDs

1. Endoscopic Balloon Dilation of the Eustachian Tubes DL38280

 

2. Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea DL38276

 

3. Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor DL37761

See Attached PDFs

 

4. Micro-Invasive Glaucoma Surgery (MIGS) DL37531

 

5. Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease DL38278

 

6. Vertebroplasty/Kyphoplasty DL33473

 

MolDX LCDs

1. MolDX: AlloSure® Cell-Free DNA Testing DL38255

 

2. MolDX: Combinatorial Pharmacogenomics Limited Coverage DL35633

 

3. MolDX: DecisionDx-Melanoma DL37725

 

4. MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease DL38292

 

5. MolDX: Erythrocyte Molecular Antigen Typing DL38240

 

6. MolDX: Molecular Microscope® Diagnostic System for the Heart DL38258

 

7. MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) DL37701

 

8. MolDX: Pharmacogenomics Testing DL38294

 

9. MolDX: Razor 14-Gene Lung Cancer Assay DL38238

 

10. MolDX: Repeat Germline Testing DL38274

 

11. MolDX: SelectMDx for Prostate Cancer DL38242

 

12. MolDX: Signatera and Minimal Residual Disease Testing for Colorectal Cancer DL38290

 

13. MolDX: Tests on Allograft Kidney Biopsy Tissue to Assess for Graft Rejection DL38260

 

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 and M. These LCDs can be found on the JM Proposed LCDs Status Report or 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 November 21, 2019. 

 

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: October 7, 2019

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

Passcode: 987225   

 

Advance registration is required. Registration is online in the Event Registration Portal and must be completed prior to September 13, 2019. 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 September 13, 2019 (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 adaptor 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 website for additional information about LCD development and for copies of the draft LCDs.