Auto transcript of CMS remarks on G0327 (July 29, 2021)

CMS PAMA advisors meeting; comments of CMS policymaker Sarah Shirey-Losso regarding G0327.

July 29, 2021 - Auto transcript

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 So regarding this code, we were in a bit of a quandary with this code, G0327. 

It was developed based on a national coverage determination that I believe CMS issued earlier this year. 

But in terms of our annual public meeting laboratories, CLFS rate setting process we have a bit of a a cart before the horse in that we a code was created, but there at this time, there isn't a test for the NCD  that would be a represented by G0327. 

We included that code on the annual lab meeting back in June where we became aware a few days before that that there wasn't actually a test associated with this code. 

Since that time, we have received a lot of comments from stakeholders during the meeting and written comments after. 

At that point, we decided that we would retain G0327 [for now]. 

It {stayed available for our} panel in the in the chance that a test did become available or were made aware of a test during before or during this meeting. So as such, to our knowledge, there is not a test associated with this NCD at this time. 

So, there obviously, no recommendations to be made from the panel or the public on possible crosswalks or gap filled. 

So I just wanted to give a few updates on that and kind of where we were the fact that the we cannot get recommendations from the panel, because we don't have information on a specific test at this time. 

Looks that we are, you know, unable to make a determination on a potential test at this time. And therefore, likely you will not see this test one our preliminary determinations document that we will have a goal to publish in mid September. 

I submit that I we wanted to acknowledge some of the comments we summarized the comments in in these couple of slides here for for awareness and that they're on the record. 

And if if there were any stakeholders that would like to speak at this time.

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Dr Bruce Quinn commented that it's a "regulation" to propose codes 30 days in advance, this was only a couple days in advance (of June 24 meeting).

Dr Paul Radensky noted that tests under this NCD would often be ADLTs, and the ability to use the ADLT pathway shouldn't be interrupted by a CMS code like G0327.

ACLA commented that the code should be pulled from current review, and please include ACLA in future discussions.

Greg Schaeffer for Guardant Health commented that it had submitted comments, thanks for acknowledging them, and supports withdrawing the code from current review.