A query- what if there is no decision made in the times mentioned. BAU??
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At the end of the day, its a gamble... But in my opinion, there are a number of factors that suggest its more likely that medicare coverage will be kept. Firstly, PEB and it's tests have compelling support from the main players in the urology industry in the USA, advocating for Medicare to be maintained. The idea is that by maintaining Medicare coverage of these tests, there is a public health benefit/overall cost saving. Secondly, Novitus will need to rebutt the Strata research and the support that this research has gained. I'm not sure if they can feasibly do this in a way that doesn't compromise their procedure and position within the time period they have. Sure Novitas can just say no, but procedurally they should back that up with sound rationale or evidence, else legally, the decision could be easily challenged and it would be a terrible look. Lastly, I think Novitas has a few options, e.g. allow coverage to be kept or raise another lcd after this one had lapsed. Of the options, these two options are safer than canceling coverage. There are some other things like elections and the FDA adding another layer of compliance and PEBs tests possibly getting guideline inclusion, these points arnt here or there but are positive for maintaining Medicare coverage.
Please DYOR, these are just my thoughts.
Is the A Bank still in on this gamble ? :)
compelling support from the main players in the urology industry in the USA
Can you qualify this please
The American Urological Association (AUA), the Large Urology Group Practice Association ,(LUGPA), and the American Association of Clinical Urologists (AACU) and Kaiser support a decision for PEB to maintain Medicare coverage. Kaiser submitted their own research to support PEB.
I'm also not sure Novitas needs rebutt a study funded by Pacific Edge?
It's on the PEB website. Some of it is here
https://www.pacificedgedx.com/news-a...-medicare-lcd/ ,but the information will be scattered across a few pages.
Nothing specific about Detect but Cxbladder is mentioned expressly in their letter and the groups advocate for Medicare coveragw for Cxbladder to be kept. There letter can e donnloaded here: https://www.pacificedgedx.com/assets...CD-DL39365.pdf
Thank you. Note as a group they argue for the continued inclusion of approved Biomarkers generally and agree, they speak positively of the results of the unpublished Kaiser findings. But note that AUA does not include the use of Cxbladder in its own Clinical Guidelines....
Wouldn't you think the AUA would first change their guidelines if Cxbladder had their support?
A podium presentation of the clinical utility was part of the just concluded AUA conference.Not sure what weight this would carry but worth to note that this conference was attended by a lot of urologists across the world.
https://api.nzx.com/public/announcem...284-417563.pdf
I'm not an expert on AUA and guidelines. Reading between the lines, I think it takes time and research for inclusion. I think PEB is gunning for inclusion in guidelines, it's just not there yet. AUA is expressly supportive of the PEB tests and they have noted this in their letter. I think the safest thing for Novitas to do is to trigger another modified LCD and give PEB another year of coverage.
This is a article pushed out a few days ago: https://auanews.net/issues/articles/...cer-management .Cxbladder is mentioned and biomarkers are talked about favorably. The science is getting there... just not sure how far or close it is for inclusion...
There is also a part that comments on guidelines:
AUA guidelines do not currently recommend the use of urinary biomarkers to replace cystoscopy, but they do provide two clinical scenarios where biomarkers may be useful: (1) to adjudicate equivocal cytology or indeterminate cystoscopic findings and (2) to assess response to bacillus Calmette-Guérin (BCG).
Yes, article talks generally about biomarkers, not written by AUA as such. Big mention re opposition too.
In the two clinical scenarios you refer to the biomarkers approved are UroVysion Fish and Immunocyt, not CxBladder.
Totally agree, getting there. But still seems some way off.
Reasonable biggish sale went last sale Friday .088.
Annual report should be out soon. Interesting time for report release given how far away a medicare decision is...
At 9 cents there is little downside risk left in the share price. With inflation, cost of living and global productivity all challenging CxBladder makes sense! It’s only a matter of time before it’s approved. Pre the first Medicare approval the shares traded at 7 cents with no cash in the bank, for me the risk v reward is worth it.
Im currently holidaying in Bali and not doing any sharetrading at all. I haven't sold any PEB and am just waiting patiently for July 26. If there's no good news on or before then, I'll just wait patiently until ift finally arrives. Just hope I live long enough to see it happen!
Hopefully we all live long enough to see PEB climb again. It's interesting that PEB hasn't pushed out its annual report yet... tomorrow is technically the last day before end of June as Friday is a public holiday. Wonder if something is going on in the background to delay the release of the Annual Report...
It's been fantastic in Bali. We had 2 weeks in Sanur and now midway through our final week in Seminyak. Sunny days and 30° degree temperatures - delightful. PEB and the market in general are way down the bottom of my list of things to think about - until I return next Monday.
I'm getting weird hopium vibes around why PEB hasn't released its Annual Report yet. Anyone else sensing this or is it just me? Nevrmind, it was just pushed out.
Report incoming...
Concerning to see the test volume (US Commercial) broke from its growth curve, collapsing from 13.5K in 2024H1 to 10K in H2.
Maybe those aren't new numbers, but the previous announcement spun it as continued growth. It's a stark drop when you see the chart.
I'm increasingly pessimistic on the outlook. Novitas' default position is to affirm the LCD to remove coverage as status quo at the end of the review period.
But even if coverage is retained, BAU is still burning cash.
(Holding a few, in lieu of Lotto tickets.)
They (Novitas) did the research, made their decisions, and published their intentions long ago. All that they have to do now is sit out the clock.
The Cxbladder determination is only a smallish part of the LCD. Even if they were to change their minds on Cxbladder, it'd be reasonable to go ahead with the LCD that they're mostly happy with, rather than go back to square one.
Rather than endlessly contesting an LCD, this commentary (discoveriesininhealthpolicy.com) points to FDA approvals and an NCD as the path to regaining coverage:
Quote:
- With complaints on "coverage decisions," historically CMS mostly tells complaining parties that if they dislike an LCD, by all means, apply for an NCD.
- And by the way, they may add that NCDs are only open to FDA-approved tests.
Isnt the default position that if Novitas don't respond, the LCD will be withdrawn? Novitas can't just sit out the clock...
Novitas will need to finalize the LCD to remove coverage. They will need to address the comments raised by PEB and the industry against the LCD...
There is also new information from PEB which can trigger a reconsideration if the finalized LCD does not already address this.
It's not news exactly, but quoting the Annual Report released today:
Quote:
We have no assurance Novitas will consider STRATA’s findings, as the study was completed after last year’s formal notice and comment period. However, if it does not, we will use the paper (in the event of non-coverage determination) to seek a reconsideration.
I found an official source for the process here: Medicare Program Integrity ManualChapter 13 – Local Coverage Determinations
A reconsideration would be after finalisation, so coverage would be lost in the meantime.
You're correct that Novitas (as MAC) does have to respond to all comments when finalising, but only those comments received during the 45-day public comment period.
Regarding the 365-day period, they don't have to wait until the end before finalising, but they're entitled to use that time and I believe have done so for previous LCDs (please CMIIW).
Worth a mention, there are provisions in the process for Novitas to request a time extension, or to amend the proposed LCD without triggering a further review, but at this stage I think it's down to a finalise-or-retire (IMO, likely finalise) decision on or before the 27th July. Then if finalised, a minimum of 45 days before taking effect.
I think the primary reason why there was another year of coverage was that Novitas did not follow the correct procedure when making their determination a year ago. This was called out by not only PEB but others too. Novitas had no choice but to go round again, this time making sure they follow the process to the letter. They have done this over the last year so there's nothing to stop them making this LCD permanent this time around, standing by their original reasons for wanting to drop coverage.
A possibility might be that they use FDA to further support their decision and drop coverage on any non-FDA approved tests. In essence making this not entirely their view but a shared view with them and FDA. Regardless PEB will lose out. I may be looking at this negatively and very happy (and hoping) to be wrong.
Disc - holding more than any sensible person should be.
There is also the following provision:
13.5.3 - Evidentiary Content
In every proposed and final LCD, the MAC must summarize the evidence that supports coverage,
limited coverage, maintenance of existing coverage in cases of LCD reconsideration or non-coverage
Can anyone see if the proposed lcd sets out maintenance in cases of lcd reconsideration for PEBs LCD? It looks like coverage during a reconsideration is still a option?
A US blog has a summary of the speeches from the commentary for the lcd. It looks like the lcd impacts FISH and PEB tests negatively?
The following comment from the AUA was quite positive for PEB (link here: https://www.discoveriesinhealthpolic...ishes.html?m=0 ):
AUA RUBENSTEIN
Dr. Jonathan Rubenstein, representing the American Urological Association (AUA), the Large Urology Group Practice Association, and The American Association of Clinical Urologists, expressed concerns regarding the proposed Local Coverage Determination (LCD) for certain diagnostic laboratory tests. He highlighted that this LCD encompasses urine markers used in the diagnosis and management of bladder cancer and discussed why these markers should be excluded from the scope of this LCD.
Dr. Rubenstein emphasized the importance of urine tumor markers in diagnosing and managing bladder cancer, citing their crucial role in screening, identifying tumors, predicting recurrence, and monitoring treatment responses. He mentioned that these markers are incorporated into screening guidelines and management strategies.
He expressed concerns that urine markers for bladder cancer, such as UroVysion and CxBladder, are not genetic tests within the scope of the LCD, as they function more like stains or immunohistochemistry rather than DNA or RNA-based tests. He argued that their clinical utility and long-standing use in clinical practice should exempt them from the LCD or be considered separately.
Dr. Rubenstein highlighted that the proposed LCD could lead to worse patient outcomes, increased costs, and conflicts with AUA guidelines, potentially exacerbating disparities in bladder cancer care. He also pointed out that restricting coverage for these markers might impact patient access and outcomes, particularly in regions with limited access to urologists.
In conclusion, Dr. Rubenstein urged Novitas to reconsider covering urine tumor markers, emphasizing their importance in managing bladder cancer effectively and efficiently. He recommended either excluding these markers from the LCD or using prior LCD guidance to determine appropriate coverage criteria, including expert input and stakeholder involvement.
Well the transcript is a signal/indicator that the urology sector in the US is against the proposed LCD. I couldn't anything about whether coverage would be maintained during a reconsideration. Anyways, hopefully there will be a update soon from Novitas.
I also didn't realize that Fish would have Medicare coverage cut by the same LCD. If Fish's funding is being cut, it makes for a stronger case that the LCD should be canceled or withdrawn.
ANOTHER BICK FROM THE WALL?
I note that “Urology Times” an online Urology journal published a summary of the STRATA study on June 19 th entitled “ Urinary genomic test demonstrates utility in cystoscopy decision- making”.
My understanding is that Fish, even if it is FDA approved and etc, will be losing coverage. This in part is why I think the LCD will be rescinded.
I think (happy to be corrected here) that Novitas can choose to remove some tests from the LCD and therefore they retain coverage but leave others in when it becomes permanent and they will lose coverage. It's not an all or none outcome. This gives them a Federal government backed middle ground to proceed along the lines of "if the FDA say the tests are good then we will cover them" I'm hoping that is not how it works out as the CXB tests are arguably the best of the bunch for Bladder cancer detection but I cannot imagine Novitas going around this cycle for 2 years only to bin the whole thing in the end and continue coverage.
It is possible that Fish and CxBladder have carve outs, but the current version of the LCD cuts coverage and this is why there has been a negative reaction from the health care industry in respect to the LCD. By analogy in New Zealand, cutting funding to CxBladder and etc would be comparable to cutting funding for breast cancer screening.
Just checking is at the end of this month we get update if LCD is rejected or accepted ? They said when annual meeting is in September they will have an answer on the legal position it looks
Yes we will know on or by 27 NZT whether PEB will keep or lose coverage.
My basic understanding of the legal position is that in the event that coverage is lost, PEB has the ability to raise a reconsideration request. It's unclear whether coverage will be provided (during the period a reconsideration is raised) and the legal position of what comes with making a reconsideration.
PEB has been very careful to communicate that it is not clear whether coverage will be affirmed or not. It is particularly interesting that a vague amount has been spent on legal fees to advise around the Medicare coverage(that is in addition to normal legal fees) and why more work on the worst case scenario hasn't been completed in advance.... the difference between the 2023 and 2024 spend on legal fees isn't big.
Test volumes June Qtr DOWN 25% on pcp
In big picture of what future is going to be this not really important
http://nzx-prod-s7fsd7f98s.s3-websit...271/422452.pdf
Market pretty skitterish after todays update !!
The communication from PEB has been confusing... I'm not surprised people have sold given that PEB appear to have miscommunicated that while a lcd decision will be made before 27 July 2024, there shouldn't be any expectations on what the result will be.
So based on last years decision it happened a week before deadline. Might make for an interesting weekend. Heads or tails
I reckon that the closer it gets to 27 July 2024, the more likely that coverage will be kept. Who knows tho...
I was thinking similar. If it was a definite no you'd think they would just say so. You would hope the Urologists in the US are requesting it. What troubles me is the corrupt nature of the US medical system and what competing treatments are doing in the background.
In the event of a shutout you'd think PEB would be a likely takeover target for a big US player with pockets deep enough to get its suite of treatments across the line.
Discl; Holding
I posted this comment late this afternoon on the Stocktalk site:
As I understand it, Friday 26 July is the final date for news of the Novitas decision. We will probably have to wait till Monday 29 for an announcement from PEB though, with the US running the best part of a day behind us.
I think that a negative outcome is highly likely and is largely factored into the current SP. However, there might be some good buying opportunities for the patient investor if the market overreacts, as it usually does, to bad news.
Conversely, it will be fascinating to see how far the SP might rise, if we get a better than anticipated result.
Fingers crossed and GLTAH. Interesting days ahead!
The vagaries of the American health system don't fill me with confidence that PEB will be able to maintain coverage. I just feel there will be much arse covering by the Novitas decision makers to justify their current stance on the product. That doesn't mean PEB will never gain coverage, but I'm sure Novitas will require more clinical evidence, lengthy independent trials, or find some other tactics to justify sticking to their position. I just can't see them backing down in favour of a little ol' company from Noo Zealand.
I hope I'm 100% wrong, though and will be delighted if I am. (Maybe I'm just trying to prepare for the worst while hoping for the best?)
Yes back to flipping a coin.
The following article indicates that US states have regulated to allow for biomarkers to be covered: https://open.substack.com/pub/sensit...utm_medium=web
Relevant part as follows :
Twenty states have now passed laws that require biomarker tests to be covered by their state’s insurance providers. The bills cover not just cancer, but any disease for which a biomarker test improves accurate diagnosis
That is positive however the laws also state:
"These bills require insurers to pay for the tests if they are
1. Prescribed by a physician, and
2. Are cleared by the FDA, recommended in practice or national guidelines, or covered by local or national Medicare / Medicaid."
Unfortunately CXB fails to meet the criteria on point #2.
Disc: Holding more than any sensible person should be
Technically if coverage is maintained, then point #2 is satisfied?
If PEB don’t get coverage they say there’s enough cash burn to work on rolling out cashflow outside this Medicare, or until it gets coverage in the future, am I reading it correct that if they don’t they will take the legal angle hoping to overturn this downstream.
Around 50 mill cash currently around 18 months remain, not forgetting ANZ chucked $75 odd mill some years back so I’m sure many would be keen for this to get accepted.
If no I’m guessing share price .03c to .05 on day one, if yes you could easily see 20c plus
My understanding is that if PEB don't get coverage, the appeals and next steps for PEB depend on how the final LCD is worded and what is covered. For example, if coverage is lost and Novitas has not considered the Strata information, PEB could ask for the new Strata information to be considered which could potentially trigger coverage for another 12 months. If the lcd is finalized in a way where the LCD is not new information and coverage is lost, I think the price will tank to 5-6cents from 8 cents atm.
If coverage is kept, or there is a further extension or the lcd is withdrawn, PEB is likely going to bounce to 25c or higher.
I still think the lcd is fundamentally flawed and should be withdrawn with more consultation with stakeholders. The support from 21c and AUA and etc are quite strong.
Disclosure- the risk is real. I have a fair bit of funds stuck in PEB.
Medical Device Coverage and the FDA
FDA’s principal role in medical device coverage is to evaluate the safety and effectiveness of medical devices for use in the United States. In general, after the FDA’s approval or clearance of a device, other organizations—for example, payors and the professionals who provide health care (providers)—decide whether to cover, pay for, use, or recommend a device.
Payors include government payors such as the Centers for Medicare & Medicaid Services(CMS), private health plans, health technology assessment groups, and others who provide input into coverage, procurement, and reimbursement decisions.
Data that medical device manufacturers submit to FDA to demonstrate the safety and effectiveness of a medical device may not always overlap with the data needed by payors to make coverage determinations. As a result, there may be a delay or denial in coverage, payment, and use of a device after it has been approved or cleared. Some decisions may ultimately delay patient access to medical devices. By communicating with payors early, manufacturers may be able to design their clinical trials to produce the data required for regulatory authorization and for positive coverage determinations, which may expedite patient access. Not only do patients and manufacturers benefit from this approach, but also payors benefit as it allows them to horizon-scan and be better prepared for novel medical devices in the pipeline.
Novitas are running this decision right to the last day by the looks of it.
Looking at it now, the news will come out anytime between the 25th and 26th during business hours US time. So we should know either Friday or Saturday nzt. Shouldn't take PEB much time to release information, as they have planned for every outcome.if news come out on Saturday nzt, we can tell via information online and peb is likely to push out information on Monday.
As a long suffering holder I’m still not confident the this will be overturned and we head down the legal front given the last update when they were dropped for coverage.
My thoughts are US time on Friday it will come out with shares in a trading half come Monday now !!!!! 3.5 - 5c range is not accepted and let’s hope for the best result which will see a nice lift to a drop of what I paid
Why on earth they would leave it to the last minute?
Going down to the wire! I think this is positive. Still in discussions.
Discl: Holding
PEB
26/07/2024 09:42
GENERAL
PRICE SENSITIVE
REL: 0942 HRS Pacific Edge Limited
GENERAL: PEB: Medicare Coverage Determination Still Under Review
MEDICARE COVERAGE DETERMINATION STILL UNDER REVIEW
DUNEDIN, New Zealand - Cancer diagnostics company Pacific Edge (NZX, ASX:
PEB) notes that Novitas, the Medicare Administrative Contractor (MAC) with
responsibility for Pacific Edge's US lab remains in discussion with the
Centers for Medicare & Medicaid Services (CMS) regarding the Local Coverage
Determination (LCD) 'Genetic Testing for Oncology' (DL 39365).
Pacific Edge expected the finalization of the LCD overnight, i.e. within 365
days of initial posting. The company reached out to Novitas for comment
overnight and was notified that: "[Novitas] is currently in discussion with
the Centers for Medicare & Medicaid Services (CMS) regarding this proposed
LCD. A timeframe for finalization is not available at this time. Please
continue to watch our website for any future updates."
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 and subject to medical necessity guidelines.
Pacific Edge continues to expect Novitas to finalize the LCD, but the
timeframe is unknown. Pacific Edge will update shareholders as it gains
certainty on the status of the LCD and the timeline for its resolution.
Pacific Edge will not be making further comment on the matter until then.
Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial
Officer.
For more information:
Investors:
Dr Peter Meintjes
Chief Executive
Pacific Edge
P: 022 032 1263
Deleted - already posted.
An interim update of sorts, with the deadline not strictly a deadline?
https://businessdesk.co.nz/nzx-announcements/435141
I was of the understanding that Novitas had to finalise the LCD within 365 days of it's creation (so 27 July deadline USA time) or it lapses and dies altogether, coverage remains. They do not have the option to continue to drag this out.
This is really confusing...the company should be in a trading halt given the uncertainty. IT looks like PEB will have coverage for another year unless a decision is released on Friday US time??
It is so difficult being an optimistic holder sometimes.
How can there be uncertainty with the timeline if the due date is 26 July 2024 US time...
Today is the 25th in the USA so still one day to go.
Don't forget 2024 is a leap year, so the deadline is a day 'early'. It was posted on 27th July 2023, so the deadline should be 26th July, meaning there's one more day (just gone COB 25th in the US).
The announcement does put a positive slant on the process for me, so I bought back a few for a flutter.
I am puzzled as to the 'expects to finalize' language in the announcement though, as I hadn't previously got the impression that PEB expects the decision to be 'finalize' rather than 'withdraw/retire'. They have said 'finalize' previously, but from context it appeared that they meant a final determination, rather than a decision to make the LCD final. Really should be clearer, and I hope they're not intentionally hiding behind the ambiguity.
Buyers/punters piling in now !
Up 10% as of time of writing. The market appears in agreement that "in discussions" is positive. I certainly see it that way.
Discl: Holding
I think that is a possible interpretation of the messaging released today but I don't think this is the correct position now. I think it is more likely that there has been a change in position and there is no timeframe to work with unless Novitas/CMS says otherwise.