Who can forget the infamous 'Several tens of thousands of tests" in 2014 after which shares were sold by directors and management?
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Agree, been so much crap over the years. Remember the mad excitement when PE signed up its first US "payor", giving access to cxbladder to squillions of Insurance customers, what a load of bollocks. Heres some more I posted this April 2021...
Newsletter quietly offers a few corrections to past embellishments I think, before a disappointing result is published next month.
The big news items taking the SP from about .10 to $1.30 over the past 10 months have been as follows:
Inclusion in NCCN guidelines
PE made much of Cxbladder being included in the clinical pathway but this was an exaggeration in the extreme.
It wasn’t.
There is no mention of Cxbladder in there at all, surveillance is still Cystoscopy and cytology. The guidelines simply, with the weakest of recommendations (2B), now say that the additional use of Biomarkers (in general) may be considered in surveillance but that it was unclear whether the additional information was useful.
Guidelines current March 2021
https://www.nccn.org/professionals/p...df/bladder.pdf
The newsletter now confirms that they have more work to do before inclusion.
Deal with Kaiser June 2020
PE finally announced completion of Triage trial with KP in Nov 2016.
We still know nothing of the Commercial deal or number of tests being paid for.
But todays newsletter confirms that they are “using” Monitor only, Triage has not been adopted by KP
July 2020 LCD by CMS
Medicare now cover Cxbladder Monitor and Detect where medically necessary
Yet the Local Coverage Decision says Cxbladder is NOT considered medically necessary
https://www.cms.gov/medicare-coverag...d=38388&ver=13
The American Urological Assn directive last reviewed Jan 2021
https://www.auanet.org/guidelines/bl...sive-guideline
It says:
9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)
So the “medically necessary” tests PEB is saying are now being reimbursed by CMS I suggest are only a small portion of those being completed. As for reimbursement of all those past tests, again, I think very few will have been “medically necessary” so good luck with that.
April 2021 United Healthcare covers Cxbladder
Well, they don’t, really. More exaggeration.
United has a Medicare Policy which is effectively back to back /underwritten by CMS as primary payer. Todays newsletter confirms that United doesn’t cover Cxbladder under its own Healthcare Plans. Neither do Aetna, Blue Cross or any others as far as I can see.
United has simply added the CPT codes so as to match Medicare for consistency
Has to be said Psychic, I know you've had a tough gig being objective in your views on PEB. For me I started to feel like you were making more sense than the positives and I made it out with my original "contribution" in part thanks to your contributions. Obviously feeling for anyone on here who remained holders but credit to you mate.
EBOS managed to get its trading halt, announcement, and trading resumption completed in an impressive time frame.
Wonder what is going on at PEB ?
Spin takes a longer time to come around?
This is damning of PEB's handling of the LCD issue : How can the company not know the timeline for the LCD? And did the company really have no inkling of the withdrawal when it made the announcement on Friday last week?
Then there are the punters who jumped in on the announcement that earlier news is good news!
https://www.nzx.com/announcements/412459
"As noted most recently in its FY 23 results announcement, released on 25 May 2023, Pacific Edge stated that it’s understanding was that Novitas, the Medicare Administrative Contractor with responsibility for its US laboratory, must either finalize or withdraw the proposed LCD (DL 39365) and the associated LCA (DA 59125) that cast Cxbladder’s continued Medicare coverage into doubt, by 28 July 2023 (NZT).
Following further review, and discussions with its advisors and other industry participants, Pacific Edge now understands that Novitas must either finalize or withdraw the proposed LCD and LCA by 9 June 2023 (NZT), 12 months after the original date of posting, not 12 months after date of last revision as previously communicated. We understand that there is no required announcement from Novitas upon passing the expiration date."
Announcement attached. https://www.nzx.com/announcements/412611
I'm not a shareholder, but does this mean the company might go out of business? I mean who is it going to sell its tests to?
Unless they have something up their sleeves, and I’m no expert in this process so there may be avenues and approaches they can take, but if this is a final determination then this could be a company killer. Will KP progress with them if there’s both doubt about coverage as well as the underlying science? Anyone else? I doubt it, but watch this space.