Here is DL39365 as mentioned in the ASX release, many words but no mention specifically of CXBladder. I guess it could be good news or bad as far as inclusion is concerned https://www.cms.gov/medicare-coverag...ntStart&bc=11#
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Here is DL39365 as mentioned in the ASX release, many words but no mention specifically of CXBladder. I guess it could be good news or bad as far as inclusion is concerned https://www.cms.gov/medicare-coverag...ntStart&bc=11#
For what it's worth, a bit of layman's research indicate that it's not looking great tbh...:
The draft coverage document (DA59125) is here:
https://www.cms.gov/medicare-coverag...Id=59124&ver=8
As far as I can see, the statement that affects PEB's codes is this:
CPT codes 81540, 0006M, 0007M, 0011M, 0012M, 0013M, 0016M, and 0017M have been added to CPT/HCPCS Code Group 6.
and further down in the document it states that CPT/HCPCS Code Group 6 is "Non-Covered CPT Codes"
Anyway, I might be wrong, but it looks to me like it is proposed that CMS cover is removed...
Wouldn't imagine this would affect SP much in either direction. Surprising a trading halt would last Monday or this. If it were talk of a takeover that would however be a different story. Likely this won't create much buy/sell pressure either way, not as dramatic as previous assumptions. Can't wait till that time comes though :)
From the information now available I strongly suspect the proposed impact on PEB is far more likely to be negative rather than positive. I doubt there would have been any need for a TH if the news was good.
Reading the document it is very clear that funding will be removed and their tests (0012M and 0013M) have been added to the Group 6 (tests of unproven clinical benefit - not funded). How long have they been promoting CX bladder - more than a decade?? If the test was so good it would have been funded long time ago. Can't shift the blame to medical fraternity. CX bladder is their only sizeable product - very risky.
This article from 2020
https://www.cxbladder.com/us/news/2020/2/