I gave up, this kind of trading volume not suit me.....
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I gave up, this kind of trading volume not suit me.....
Ops I thought the links to the lcds were down but they look to be online now..
This was posted on the other site.
Novitas has been granted an extension https://www.novitas-solutions.com/we...entId=00006150
No timeframe provided.
Also discussed on this blog https://www.discoveriesinhealthpolicy.com/
The news is positive in my opinion (less positive than if the lcd was withdrawn but still positive).
Reading into this, I suspect what has happened is that CMS has told Novitas that it is not on the right path and that significant time will likely be needed to have the LCD in a state where it is workable to advance. CMS could have given Novitas a 1 or 2 week oe 1 month extension (something with certainty), instead it has provided a indefinite extension. Firstly, for me this indicates that significant and careful reworking of the proposed LCD is required, else a shorter extension would have sufficed. The wording "An extension has been granted by CMS in order for all comments to be considered thoroughly", reads for me, that Novitas did a bad job with addressing comments and submissions. I wouldnt be suprised if one of the points that Novitas is having a hard time with addressing are the submissions made which indicate that Novitas is acting outside of powers and setting a incorrect threshold via reliance on the external knowledge bases (PEB, AUA and 21 and other parties commented on this). It is possible that the extension length is not indefinite however based on the email from Novitas and the the unstated nature, I suspect it is indefinite until otherwise.
Secondly, i also think that CMS and Novitas are going to be extra careful. An indefinite extension outside what is allowed puts both CMS and Novitas at risk of procedural unfairness and risk of litigation (from several companies). This second point could be potentially very powerful for the companies as it is incredibly unfair for CMS and Novitas to subject PEB, the other companies and Medicare users to so much uncertainty for a unstated period of time.
What I think will happen moving forward is that Novitas will take a long time to finalize the lcd and what will most likely happen as a outcome is that there will be something new to be worked with that has been built with consultation with stakeholders. During this time, this should provide PEB and other impacted companies with room to meet requirements.
This could represent a change in position which is significant and positive for the PEB but there are risks also.
Disc: holding, DYOR
"The wording "An extension has been granted by CMS in order for all comments to be considered thoroughly", reads for me, that Novitas did a bad job with addressing comments and submissions.
I wonder how much more time Novitas will need if they couldn't consider all comments thoroughly in ten months!
I agree it is extremely unfair to subject PEB and others to ongoing uncertainty for an unspecified amount of time.
Medicare users and doctors will also be impacted. I'm unsure if PEB needs to reword it's disclaimer. Before the disclaimer could have read that cover may drop after 26 July 2024, now it's working with cover that could drop any week, how do u work with that as a medicare user or doctor lol
Ah yes, you are correct. Doctors and Medicare users could then work with a disclaimer that any tests needs to be submitted and reimbursed within 45 days. I'm not sure how long PEBs tests take or how the reimbursement process works, but that might work.
It is still heavy burden of uncertainty.
Given the botch up of all sorts by Novitas and the uncertainty surrounding it, PEB should take them to court. It’s quite unfair for all the stakeholders to be kept in limbo.
Thoughts on how the market reads this on Monday?
I think PEB may need to provide a update on the extension provided by CMS to the market as the extension is new information technically. If PEB come out strong and says this is positive news, which while bringing uncertainty, could also bring more time for research milestones to be met, then I think the market reacts positively.
Craigs, Forsyth and etc all modeled PEB with pricing of around 12c and comments that a negative coverage decision would have been made on or by 26 July 2024. PEB should use the opportunity to update the market and the investment houses. The consensus has always been that PEB just needs more time to get research across the line to keep coverage. This is technically more time but also carries a fair amount of uncertainty still (but still a more positive position than what shareholders were in before 26 July 2024).
If PEB push out a positive update, I think PEB goes up alittle further. Else it will trade flat around the current range.
It is possible that PEB may also need to indicate to the market that it is not clear whether they will maintain or not maintain coverage by the September catch up pending a decision from Novitas.
Was checking other companies which are listed to see any announcements…(same issue with CMS)…PancraGEN”s parent company has no announcements made( even along the lines of what PEB has made) …
https://ir.interpace.com/press-releases
One may say that Novitas has one job to do and considering this is their 2nd swing at this and they have botched it up again, they are not doing that one job very well at all. Regardless, PEB and others are at their mercy it would appear. Here's a link to the LCD process as well as links to the various laws that apply here for anyone interested https://www.cms.gov/cms-guide-medical-technology-companies-and-other-interested-parties/coverage/local-coverage-determination-process-and-timeline with further info here https://www.cms.gov/Regulations-and-...s/pim83c13.pdf.
Perhaps PEB need to investigate other markets, far too stressful for shareholders with almost all their eggs in the USA basket. I wonder why the UK is essentially untapped by PEB?
if at all it will be irrational
too murky to read between these lines
I get the feeling Novitas are too understaffed to deal with the complexities - not just with PEB but the other companies affected with reimbursement decisions.
PEB may have been pushed down their priority list
Is Novitis a private company given the job of approving the products for LCD ?
Are the potentially on the hook for massive legal issues if the product is good but they can’t work to a time line ?
Am I reading it correct that as there’s “no specific” time for the update due to reviewing that we will keep receiving payments until it’s been determined?
I’m tempted to double down to bring down my horrific average cost closer to break even 🤧
Novitas can be sued but it would be best for PEB to give guidance on this.
Yes PEB will keep getting payments until a determination has been made in respect to the LCD.
Let's see how the market reacts and if PEB pushes out any messaging.
And here it is
Dear Shareholder,
Pacific Edge notes that Novitas, the Medicare Administrative Contractor (MAC) with responsibility for Pacific Edge’s US lab, has confirmed that it has been granted an extension to finalize or withdraw the Local Coverage Determination (LCD) ‘Genetic Testing for Oncology’ (DL 39365).
In a post on its website on Friday (Saturday morning NZDT), the MAC noted: “Novitas is considering all the feedback from interested parties regarding the Genetic Testing for Oncology LCD. An extension has been granted by the [Centers for Medicare & Medicaid Services] in order for all comments to be considered thoroughly. Future updates will be published to this website and the Medicare Coverage Database.”
Pacific Edge expected the LCD, which could impact Medicare coverage of its Cxbladder tests, to be withdrawn or finalized last Thursday evening (NZDT), i.e. within 365 days of the initial posting.
The continued deliberation on the LCD means that Pacific Edge’s tests Cxbladder Triage, Detect and Monitor continue to receive reimbursement from Medicare and Medicare Advantage payers in line with historical reimbursement rates, subject to medical necessity guidelines.
Pacific Edge continues to expect Novitas to finalize the LCD, but the timeframe is unknown. It will update shareholders as it gains certainty on the status of the LCD and the timeline for its resolution, but will not be making further comment on the matter until then.
I can make out a clarification in today's tea leaves, on the meaning of 'finalize': note 'finalize or withdraw' ... 'withdrawn or finalized' ... 'Pacific Edge continues to expect Novitas to finalize'.
That is, Pacific Edge does not expect Novitas to withdraw the LCD.
I think the extension could be seen as the 2nd best outcome for PEB. Obviously would have preferred full inclusion, but the extension continues revenue streams, enables more urologists to prescribe the tests, and sends a signal that Novitas realises it can't dismiss this form of testing. A hard NO would have been easy for them.
Discl Holding
Market does not like atm .
Peb haven't done a good job of communicating what type of finalization they expect... My understanding is that a decision that allows PEB to keep coverage also fits within the realm of finalized decision... if the market is reacting negatively due to the communications, that's for the market to do.
This company is very interesting. Time to buy again, but I just cannot....trading volume too small.
I also follow Interpace Diagnostics on the US market facing a similar situation to PEB, they appear to have a much more positive take on the situation. Here's their announcement. https://finance.yahoo.com/news/inter...122500510.html
Up almost 35% overnight on this news.
Disc holding PEB
What worries me is that PEB is a growth story. It's going to bleed cash and effectively be gimped by the extension and uncertainty... which is really unfair.
The positive is that PEB's tests are covered while the LCD remains in limbo. Currently though , once finalized, coverage will cease. There's no other way to spin it without bending, or leaving out the facts.
Will it be withdrawn? Who knows... i wouldn't put 30k on a heads or tales bet. Escpecially when one side of the coin is already heavily weighted.
Interpace Diagnostics has a market cap of 8.5million ish NZD and a positive EBITDA where PEB's is $73m and loss making... Not really comparible
Someone really is desperate to get out .
SP notice will tell us soon. I am picking ANZ- has 88M in 2023. Which is about 10% of the total equity base.
AUA Journal of Urology Editorial Supports Cxbladder. Inclusion in AUA guidelines will be a game changer for PEB. Hopefully it comes in time..
For those interested but not subscribed to PEB's mailing list:
Quote:
AUA Journal of Urology Editorial Supports Cxbladder
Dear Shareholder,
Pacific Edge welcomes an editorial in the American Urological Association’s Journal of Urology supporting the use of Cxbladder to reduce unnecessary cystoscopies on patients at risk of bladder cancer.
Published in the September issue2, the editorial - entitled ‘What Is the Future of Cystoscopy for Detecting Urothelial Carcinoma?’ – focuses heavily on evidence pointing to the clinical value of Cxbladder in helping clinicians to evaluate patients both presenting with hematuria and those under surveillance for bladder cancer recurrence, specifically citing the recent STRATA3 study that demonstrated the clinical utility of Cxbladder Triage.
The editorial notes: “Although these novel biomarker studies raise important questions about evaluating patients at risk for UCB4, these tests have the potential to improve the management of our patients with suspected UCB who would otherwise require an invasive procedure for diagnosis. This also holds true for nonmuscle-invasive bladder cancer patients who require cystoscopic surveillance.”
Pacific Edge Chief Executive Dr Peter Meintjes said: “We are delighted to see our Cxbladder test recognized in the Journal of Urology editorial. Such supportive commentary on our recent clinical evidence in such an influential urology journal shows how leading urologists are coming to understand the clinical value of our tests in hematuria evaluation and monitoring patients for the recurrence of bladder cancer.
“It reinforces both our first-mover advantage in the commercialization of urine biomarkers of bladder cancer and the importance of clinical utility studies in updating the standard of care. It also provides further validation of our investment in medical affairs to educate the urological community on the value of our tests and our investment into our clinical research program, which we have configured to deliver the end points required for coverage decisions and guideline inclusion. We expect this editorial to build further momentum in the adoption of Cxbladder.”
Authored by Journal of Urology Assistant Editor Christopher Anderson, the editorial first critiques the AUA’s guidelines for the evaluation of asymptomatic microscopic hematuria, which it says results in urologists performing many unnecessary cystoscopies and missing opportunities to evaluate at-risk patients.
It then focuses on the clinical evidence to overcome these limitations, regularly referencing Pacific Edge’s STRATA study, which was published in the May edition of the Journal of Urology. The study showed clinicians undertook 59% fewer cystoscopies if they were able to use the information generated by a Cxbladder Triage test. The editorial also notes the potential cost savings that come from reducing unnecessary procedures using non-invasive urine-based biomarkers such as Cxbladder.
The editorial concludes by acknowledging the continued need for cystoscopy in bladder cancer diagnosis but underscores the importance of reducing negative cystoscopies.
“If these biomarkers are employed in the first-line setting, it may ultimately improve appropriate hematuria referrals to urology and avoid the referral delays that some hematuria patients face… we are challenged to understand these tests, educate patients about them, and determine how to best incorporate them into our practice.”
1 PEB has not released the information contained in this update to the NZX and ASX as it regards it to not be material, as defined in the NZX Listing Rules and Section 231 of the FMC Act.
2 Anderson C. (2024) What Is the Future of Cystoscopy for Detecting Urothelial Carcinoma? J Urol. Vol. 212, 399-400, September 2024
3 Lotan et al (2024). A multicenter prospective randomized controlled trial comparing Cxbladder triage to cystoscopy in patients with microhematuria. The safe testing of risk for asymptomatic microhematuria trial. J Urol. Published online May 3, 2024.
4 Urothelial Bladder Carcinoma
Market likes this ann,