Header: Why do some MolDx LCD's have paragraphs citing "expert opinion," and others dont?
A frequent question I get is, can we submit "expert opinion comments" along with our LCD request? Or, should those expert opinions be submitted much later, if and when MolDx decides to open a draft LCD?
We should be able to get a clue, from how MolDx handles actual LCDs.
When a final LCD appears, all MACs are required to include an online supplement that reviews all comments submitted during the public comment phase - this is separate from the LCD, but hotlinked to the LCD. (In contrast, NCDs include an embedded discussion of public comments, both arising in the first comment phase, which usually precedes a draft, and arising in the second comment phase, on the public draft.)
The MolDx LCD for pharmacogenomic testing (L38337) is associated with an online comments supplement (A58238) but it also included an extensive summary of expert opinion back in the first draft of the proposed LCD (DL38337). I've extracted the expert summary in the body of the LCD, here.
Why This Happens?
The answer lies in the CMS instruction manual for LCDs which is "Program Integrity Manual Chapter 13." Last revised in 2019. A "CAC" is a Contractor Advisory Committee with expert speakers and is held as a public webinar.
I paraphrase as follows: When a MAC seeks CAC consultation for a proposed LCD, the CAC's recommendations must be included in the final LCD, along with clear details of the CAC meeting. Consultation frequency is at the MAC's discretion. During LCD development, MACs should use clinical guidelines, consensus documents, or expert consultation, informing and obtaining consent from experts for public disclosure of their opinions in the LCD. Expert acceptance does not imply general medical community acceptance.
So, when a MAC holds a CAC (advisory meeting) ahead of the draft LCD production, the MAC is required to clearly detail the results in the body of the draft LCD. This can include live CAC comments and also, expert opinion solicited by the MAC "for the CAC" but delivered in writing instead. This is why we see the extended discussion of both live comment, and written KOL opinion, in the draft PGx LCD.
In October 2023, MolDx held a open public comment session on 3 proposed-LCD topics. (See links here). Where does that fall? Nowhere! The MAC isn't required in any of the rules to specifically respond to verbal open comments, though it must hold a verbal open comment meeting. However, assuming the speakers submitted written documents (like PPTs and memos) the MAC must respond to written public comments in its attached public comments article for the final LCD.
QED: By inference, expert opinion submitted early (with a dossier) may or may not be entertained by the MAC, at the MACs discretion, but such statements don't have to be cited in the LCD as they are neither (1) CAC-solicited comments nor are they (2) written open-comment-period comments.
As a result, some LCDs have extensive embedded citation of "expert comments" and others do not.
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