PEB-Pacific Edge

[LoungeLizard]

Agree with comments that this isn't the end of the road for PEB even if Novitas stick with the LCD. The District court although conceding it doesn't have the authority to hear the case has made it clear that PEB have a compelling product and implies that appealing to another jurisdiction that does have authority may well be successful. And of course CMS could extend the coverage again or even instruct Novitas to rescind the LCD. Or Novitas may finally see sense and rescind the LCD itself, although it is cutting it fine if it is going to do that. So many scenarios that have yet to be played out. Meanwhile the real world evidence of CXBladder's positive impact on patient care and diagnosis continues to stack up and further endorsement from the AUA is likely. 

[Greekwatchdog]

A piece out of Herald tonight..

Pacific Edge also had a lot of movement today, with its share price falling by 7.32% to $0.11, with 257,628 shares trading hands to the value of $30,423.60.

Goodson said the market will be looking to the decision out tomorrow on whether Pacific Edge will lose coverage under Medicare and Medicaid in the US.

"That would be a ludicrous outcome, because they've been included in the American Neurological Association guidelines with quite helpful wording.

"We don't know if they'll lose coverage or whether CMS [Centres for Medicare and Medicaid Services] has been waiting for the outcome of this court case, and the court said they lacked jurisdiction to try it."

Good Luck to all of us tomorrow. If its negative its only a setback, ultimately AUA inclusion in the guidelines speaks volumes for CXB.Product

[bulltrap]

A piece out of Herald tonight..

Pacific Edge also had a lot of movement today, with its share price falling by 7.32% to $0.11, with 257,628 shares trading hands to the value of $30,423.60.

...

Good Luck to all of us tomorrow. If its negative its only a setback, ultimately AUA inclusion in the guidelines speaks volumes for CXB.Product

To be precise, it fell from $0.123 at close yesterday, to $0.114 today. NBR needs to add an extra digit to their widget. (PEB's own Investor Centre is even more misleading, showing a price of $0.110 for NZD on the NZX - although coincidentally this would be correct in AUD on the ASX.)

I don't think there's a go/no-go decision needed from CMS at this point, as the old LCD was already superseded and just counting down to the new effective date.

It's frustrating that the AUA guidelines revision already invalidated a pillar of Novitas' argument supporting the LCD, before it took effect, but to be fair those guidelines did only come out recently. Guess we'll need to be patient with the process. If a new LCD revision is what's needed to reinstate coverage, hope it doesn't take years this time around.

Meanwhile, addressable market still includes US private insurance and the rest of the planet. Medicare coverage was nice while it lasted, but hasn't been enough to turn a profit.

Disc: Faithfully holding

[Greekwatchdog]

Posted on other channel.

Not good news!! A difficult and frustrating read......
https://www.cms.gov/medicare-coverag...relevance&bc=1

[Left Field]

Thanks for posting

The above link didn't work for me..... but this one did.

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=28&keyword=Cxbladder&keywordType=starts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1

Yes bad news it would seem.....BUT

This sentence in the determination interested me....

"Enhanced Cxbladder Triage and Cxbladder Resolve are removed since they are not yet commercially available."  ??

Has the door been left open?

Can PEB  now work to make these two tests available commercially and have them included?......... Probably way too simplistic.

PEB's response to todays news will be interesting.

From Jonu on the other side....

Extraordinary. They still don't acknowledge the AUA guidelines amendment from February, but say as of the 2024 AUA guidelines, CXBladder isn't recommended. It appears they haven't caught up with it yet. By their own logic, the decision can't hold once they incorporate the update. You have to ask the question of competency or corruption here. I hope the AUA gets stuck into them.

I expect it will be a negatively volatile period for the share price while it gets sorted, but the decision can't stand. I might look for an opportunity to accumulate if the share price plummets.

Discl;Holding

[LoungeLizard]

A terrible, frustrating and illogical decision from Novitas. Par for the course, unfortunately, as PEB have come up against vested interests, bureaucratic inertia and dare I say it, possible corruption. Thats the US Health system for you! The door has been left open though if the AUA get further involved and CMS do their job in making sure the system works for the patients rather than corporate interests. Will be interesting to see how PEB respond and how much of a pummelling the SP gets. A capital raise might have to be considered if lengthy legal action is taken and revenue plummets.

[850man]

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=28&keyword=Cxbladder&keywordType=starts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1

Nothing has changed in this LCD since January, the wording is identical and it's just that the date has ticked over past 24/4/2025. There has been no reference made to AUA 2025 guidelines which include the use of CXbladder in microhematuria diagnosis with a "strong" recommendation, the STRATA study or the very recent Kaiser Permanente study with a 3353 patient sample size, all of which prove the value of CXBladder in improved patient outcomes and cost reduction over present methods. It could be argued that Novitas has failed to correctly assess the clinical value of CXBladder in the light of all the current information. That may be the approach PEB uses directly with CMS. Tough times continue for those of us still keeping the faith.

[LoungeLizard]

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39367&ver=28&keyword=Cxbladder&keywordType=starts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1

Nothing has changed in this LCD since January, the wording is identical and it's just that the date has ticked over past 24/4/2025. There has been no reference made to AUA 2025 guidelines which include the use of CXbladder in microhematuria diagnosis with a "strong" recommendation, the STRATA study or the very recent Kaiser Permanente study with a 3353 patient sample size, all of which prove the value of CXBladder in improved patient outcomes and cost reduction over present methods. It could be argued that Novitas has failed to correctly assess the clinical value of CXBladder in the light of all the current information. That may be the approach PEB uses directly with CMS. Tough times continue for those of us still keeping the faith.

Yes, Novitas seems to be almost wilfully ignoring all recent studies, real time results and the AUA's endorsement in order to stick with their original assessment. Why they are doing it, is the real question. There would be no contradiction - it would make perfect sense - for Novitas to renew coverage based on all the new evidence, but they refuse to do so. It's now up to CMS to issue Novitas with a "please explain" and if they can't do so, then formally be instructed to renew coverage.
This is going to run and run unfortunately.

[bulltrap]

Catching up on this, it was claimed back in January (see Discoveries in Health Policy coverage and their update this week) that the reason for the LCD effective date delay was for the 'incoming Trump administration' (not CMS specifically) to review evidence for Interpace's PancraGEN tests (not CxBladder), which was also losing coverage.

For what it's worth, Trump's appointed CMS head, Dr Mehmet Oz, was only sworn in a week ago. He may've had some higher priority items on his todo list.

Was there ever an announcement that CMS was actually taking the opportunity to reconsider CxBladder coverage - other than PEB pointing out that (in theory) they could? I'm puzzled why folks were seemingly expecting CMS to step in at the 11th hour and overrule their contractor's decision.

I was also trying to find info on what proportion of PEB's tests were being reimbursed by CMS or otherwise at risk. Mostly their reporting doesn't break this out. The 2025 Q3 investor update does mention Medicare (perhaps, not including Medicare Advantage) accounts for 54% of US commercial tests. For 2023 FY 60% of test volume (77.3% of revenue) was at risk from the LCD, which includes Medicare (CMS reimbursed) and Medicare Advantage (private) plans.

I'm wondering if the effect on private Medicare Advantage plans is automatic and immediate, or if United Healthcare (in particular) has to formally confirm coverage loss. Does anyone have better info on expected impact?

Also for perspective, Kaiser Permanente is a top health insurer in the US still covers CxBladder, but only has less than 10% market share. Armed with updated AUA guidelines, PEB salesforce should have a better chance to sway other private insurers to get on board.

[Greekwatchdog]

For Bars review

Pacific Edge (PEB) remains set to no longer receive reimbursement for its Cxbladder tests from CMS in the US. CMS has announced that it has revised its local coverage determination (LCD), with no substantial revisions of note for PEB. The revised LCD became effective on 24 April 2025 (US time). CMS represented ~60%–70% of PEB's revenue prior to the recent slowdown and remains its largest market and key growth driver. This is a big blow—but all is not necessarily lost. In light of the positive American Urological Association (AUA) guideline outcome in February 2025, and updated evidence since the initial LCD, we expect PEB to lodge a reconsideration request, which could reverse the decision. If unsuccessful, we expect ongoing clinical evidence generation investment and a further operational battening down of the hatches. We expect PEB to update the market, but near-term plans will undoubtedly involve the active pursuit of a reconsideration. With net cash of ~NZ$23m at FY25 on our estimates and cash burn of ~NZ$2m a month, timelines are tight.

A big blow (again...)


On 27 January 2025, it was announced that Novitas extended the final LCD commencement deadline by 60 days to allow for revisions. Unfortunately, the scope of revisions (which appear negligible) still means PEB's Cxbladder tests will no longer be covered by CMS. At this point, the LCD is final and became effective on 24 April 2025.

Next steps


PEB will likely update the market with its next steps. In the near term, a reconsideration request will be lodged. PEB stated in its latest quarterly update it 'will use the new guideline, and the evidence ignored by Novitas as it finalised the LCD (including the STRATA study and updated analytical validation studies of Triage and Detect)'. Novitas has not taken these updates into account, and under current legislation, Medicare contractors are required to consider guidelines in determining coverage. We see solid grounds for reconsideration, but given Novitas' behaviour over the past 33 months, this is hard to call. Medicare contractors have 60 calendar days to respond. If successful, the LCD will be reopened and a new process will commence. If unsuccessful, PEB has previously mentioned: (1) further cash burn reduction initiatives, and (2) exploring strategic alternatives. Legal action is now off the table, with the US district court unable to consider the merits of PEB's complaint. Regarding cost initiatives, we expect ongoing evidence investment as a mechanism to regain coverage and improve adoption. We forecast FY25 net cash of ~NZ$23m (NZ$28.5m at 31 December 2024). At current burn rates, this represents less than 12 months of cash on hand. Based on PEB's pre-CMS opex base, general inflation, and research cost uplift, we expect opex to fall significantly to ~NZ$34m in FY26 (from ~NZ$59m in FY24). We acknowledge there is a chance PEB could cut opex further, but suspect no decision will be made until the reconsideration outcome is delivered. Outside CMS, revenue growth has been encouraging (driven by the US), but at revenue of ~NZ$10m in FY25E (growth of ~+45%), it remains small relative to PEB's opex base and the prior CMS contribution.

[Poet]

Trading Halt this morning. Wonder what's up

[850man]

Reason for trading halt:
Pacific Edge is aware the Centers for Medicare and Medicaid Services
(CMS) has published the draft Gapfill prices for Cxbladder Triage Plus with the median price of
US$1,018.44.
Pacific Edge is currently reviewing the prices and the associated documentation and needs time to
assess the implications of them, consult with its advisers and industry partners, and prepare an
announcement that provides context to investors.
It expects to provide an update to the market, at the latest, before the opening of trading on 30 April
2025.

[Poet]

Here is what PEB said in January 2025

 TRIAGE PLUS COMMERCIALIZATION
 The success of the negotiations with BCBSTX,
BCBSIL and Wellmark reflects the effectiveness
of clinical utility data from our STRATA study, a
prospectively enrolled randomized clinical trial that
demonstrated Cxbladder's clinical utility in helping
clinicians to safely and more effectively risk-stratify
low-risk hematuria patients when compared to
AUA guidelines. For healthcare payers, the study
highlighted the benefits of using Cxbladder to
improve patient care and optimize resource use.
 CMS confirms Gapfill to price Triage Plus 
The Centers for Medicare and Medicaid Services (CMS) has affirmed it will follow a Gapfill process to price
Cxbladder Triage Plus, the company's second generation Cxbladder test for hematuria evaluation. The
CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed for all patients with Medicare
and Medicare Advantage insurance. 
CMS agreed with the Pricing Panel that Gapfilling Triage Plus was more appropriate given its view that
there were no suitable crosswalk candidates in the current CMS Clinical Lab Fee Schedule. Gapfill requires
all Medicare Administrative Contractors to recommend an initial price each year in April, and to follow a
notice and comment process that is only finalized in late November.
 We continue to focus on preparing our US laboratory for running Triage Plus at scale and will work
with Novitas on provisional pricing for Triage Plus to ensure that a Gapfill recommendation is not limiting
our ability to launch the new test with reliable reimbursement. We remain confident Triage Plus will
achieve a price that will deliver a greater margin both in nominal and percentage terms than the current
generation of products, underpinning our drive towards long-term financial sustainability

[raW tent Buffer]

Sounds to me like they expected/wanted the amount to be higher?

[Poet]

Sounds to me like they expected/wanted the amount to be higher?

the re-imbursement price for cxbladder when it first gained coverage in 2020 was $USD760 so $US1018 for triage plus probably isn't all that disappointing.
All a bit moot though isn't it? until they can get coverage.