Wednesday, November 2, 2022

MolDx Will Hold Meetings on Organ Rejection Tests

On its public meetings page, MolDx now lists two meetings on the topic of testing for organ rejection.

On November 16, they will discuss tests for kidney and liver graft rejection.

On November 17, they will discuss tests for heart and lung graft rejection.

Generally, MACS post transcripts of the meetings a few weeks later.  Sometimes it's tricky to find where one of the MACs stores these transcripts.  At Palmetto, they are on file here.

Find more information here (note the Nov 16/17 events are on the CAC tab and are indexed by the announcement date 10/31):

https://palmettogba.com/palmetto/jmb.nsf/DID/U0I2M2TFO0

Noridian has updated its website with some text around the CAC purpose.
The Centers for Medicare and Medicaid Services (CMS) assigned Noridian Healthcare Solutions, Jurisdiction E and Jurisdiction F the task of developing Local Coverage Determinations (LCDs). 

Noridian requested an internal reconsideration of the Molecular Diagnostic Testing for Acute Rejection LCD after noting unexpected utilization patterns that are outside of expectations based on evidentiary review and manufacturer documentation. 

The A/B MACs participating in the MolDX Program seek to learn from the experts’ analysis of the selected literature regarding the clinical utility of molecular diagnostic testing for acute rejection. The SME discussion may inform proposed revision(s) to relevant policy (LCD) as part of a contractor-initiated internal reconsideration. 

The purpose of the CAC meeting is to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing the LCD and promote communications between the MAC and the healthcare community. For this CAC, invited Subject Matter Experts (SMEs) are asked to examine and discuss selected published articles related to Molecular Diagnostic Testing for Acute Rejection in Heart, Lung, Kidney and Liver Allografts and rate their level of confidence in the literature by responding to a series of Key Questions. During the CAC meeting, discussions between the invited SMEs and contractor (CMD) facilitator(s) will be recorded. Any stakeholders and the general public are invited to register for this meeting and listen to these discussions in real-time; or they may also listen to a recording of the meeting and access a transcript of the discussion posted to the contractors’ website following the event.

Some contacts immediately asked me, what does this mean:  "utilization patterns that are outside of expectations."   I have no idea, directly.   Possible considerations would be, for example, if testing was biweekly and they expected monthly, or if monthly if they expected quarterly.  My memory is that these LCDs are pretty vague on indications for testing, or frequency of testing, and now after a year or two MACs are facing the results of the vagueness.   The way the paragraphs are written also suggests there may be some daylight between what the Noridian team thinks and the MolDx full-time team.

The description of the same meeting on the Palmetto website is a little different.


Noridian Healthcare Solutions along with Palmetto GBA will host a Multi-Jurisdictional Contractor Advisory Committee (CAC) Meeting via teleconference on November 16, 2022, from 2–4 p.m. CT. Discussions will focus on Molecular Diagnostic Testing for Acute Rejection in Kidney or Liver Allografts. 

The Centers for Medicare and Medicaid Services (CMS) assigned Medicare Administrative Contractors (MACs) the task of developing Local Coverage Determinations (LCDs). The purpose of the CAC meeting is to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing the LCD and promote communications between the MAC and the healthcare community. The CAC panel will be asked to discuss the clinical literature related to Molecular Diagnostic Testing for Acute Rejection in Kidney or Liver Allografts and rate their confidence in a series of Key Questions. Discussions will occur between CAC panelists and Contractor Medical Directors. The public may attend; however, questions from the public will not be entertained. 

Interested stakeholders are invited to listen via teleconference; however, advance registration is required. Registration is available at CVENT Kidney or Liver Allografts.

Once registered you will receive the teleconference information via email prior to the meeting. Lines will remain muted throughout the conference except for the invited CAC panelists and the MAC hosts.