PEB-Pacific Edge

[LoungeLizard]

A continuation of the holding pattern that PEB have been in ever since the initial Novitas decision. Management can't really do any more than they are already doing - have the decision independently reviewed, continue working with Novitas and the AUA, prepare to file an injunction and then very possibly make a legal challenge.
Incredibly damaging and destabilising for the company.They must be tearing their hair out wondering what more they can do to get Novitas to see reason. An envelope stuffed with cash perhaps?

[Pierre]

It is incredible that Novitas published their latest decision without reviewing the results of the STRATA study, which they originally agreed to include.

This omission, plus hopefully, the inclusion of CxBladder in the AUA Standard of Care Guidelines, must surely provide PEB with a reasonable basis for a further reconsideration of their case for reimbursement by CMS.

In addition, the existing support of Kaiser Permanante and now Blue Cross Blue Shield adds further weight to PEB's case.

All is far from lost, but the time required to reach a successful outcome is a big issue. Maybe a phone call to RFK in his new role in the Trump circus might be a worthwhile investment?

[lorraina]

https://stockhead.cmail19.com/t/d-l-sjjtug-yupddjlly-i/

[Greekwatchdog]

This mornings announcement

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) advises the date at which the 'Genetic Testing in Oncology: Specific Tests' (L39365) Local Coverage Determination (LCD) comes into effect has been extended by two months until Thursday 24 April 2025 (US time) from the original date of Sunday 23 February (US time).

The change in effective date was observed on Sunday morning NZT after an off-schedule update to the Medicare Coverage Database overnight. The update contains no explanation, but follows representations by Pacific Edge to Novitas, its parent company GuideWell, the Centers for Medicare & Medicaid Services (CMS), the US Department of Health and Human Services Office of the General Counsel (OGC), and incoming political leadership to have the LCD revised or withdrawn.Pacific Edge will update shareholders as more information comes to hand.

[Pierre]

What a weird outfit that Novitas appears to be.

They release their LCD decision without considering significant evidence such as the STRATA review, then they push out the implementation date of the cancellation of CxBladder coverage by a further 2 months without any explanation.

While this hopefully may signal good news for PEB, it's a pretty strange way of doing business.

Maybe it's time for PEB to request a review of the competence of Novitas to continue in its role in this saga?

[Left Field]

What a weird outfit that Novitas appears to be.

They release their LCD decision without considering significant evidence such as the STRATA review, then they push out the implementation date of the cancellation of CxBladder coverage by a further 2 months without any explanation.

While this hopefully may signal good news for PEB, it's a pretty strange way of doing business.

Maybe it's time for PEB to request a review of the competence of Novitas to continue in its role in this saga?

I suspect this extension is due to the fear of well founded legal action by PEB.

[LoungeLizard]

What a weird outfit that Novitas appears to be.

They release their LCD decision without considering significant evidence such as the STRATA review, then they push out the implementation date of the cancellation of CxBladder coverage by a further 2 months without any explanation.

While this may hopefully signal good news for PEB, it's a pretty strange way of doing business.

Maybe it's time for PEB to request a review of the competence of Novitas to continue in its role in this saga?

Yes, their decision making process looks amateurish but there are lives at stake in what they do.

I agree with  LF that PEB's application for an injunction together with the threat of an independent review and/or legal action, might have Novitas running scared. Their decision making clearly doesn't make any sense and they would have a hard time justifying it in court. Getting the Department of Health involved again might also be putting them under pressure, considering it was the DOH who were critical of the process surrounding their initial decision to withdraw coverage.

Who knows what will happen in two months time??? 

[Magic78]

Some more info on the LCD delay here https://www.discoveriesinhealthpolicy.com/2025/01/genomeweb-scoop-novitas-delays-cancer.html?m=1

Suggests the delay is driven by another company, Interepace.

[LoungeLizard]

Some more info on the LCD delay here https://www.discoveriesinhealthpolicy.com/2025/01/genomeweb-scoop-novitas-delays-cancer.html?m=1

Suggests the delay is driven by another company, Interepace.
[/quot

Some more info on the LCD delay here https://www.discoveriesinhealthpolicy.com/2025/01/genomeweb-scoop-novitas-delays-cancer.html?m=1

Suggests the delay is driven by another company, Interepace.

Very interesting.
 I see this as being a good thing as clearly other companies  trying to get coverage for their products (in this case in detecting pancreatic cancer) are also being affected and are putting pressure on Novitas as well. And the fact that CMS and Novitas are now having to consider whether the proposed LCD is going to get the support of the Trump administration is also a good sign, I think. RFK jr is known to be critical of the high cost of health in the US (and it's resistance to new ideas) so maybe he could turn out to be the white knight that saves PEB.    

[Greekwatchdog]

Senate just voted in RFK to HHS Secretary. This is good news IMO as the administration is sick of these high costs in the sector.

I guess time will tell. Meanwhile we wait on AUA to address guidline inclusion.

[LoungeLizard]

PEB's rebuttal to Medicare LCD Evidence:

https://www.pacificedgedx.com/assets/Investor-Files/Pacific-Edge-Medicare-LCD-Evidence-Rebuttal.pdf#msdynmkt_trackingcontext=6d235503-62de-4560-a296-85fb990470d6

[Greekwatchdog]

PEB's rebuttal to Medicare LCD Evidence:

https://www.pacificedgedx.com/assets/Investor-Files/Pacific-Edge-Medicare-LCD-Evidence-Rebuttal.pdf#msdynmkt_trackingcontext=6d235503-62de-4560-a296-85fb990470d6

Certainly is, ultimately they need the AUA to include in the Guidelines then there is no argument.

[Greekwatchdog]

Finally

Cxbladder Incorporated into AUA Clinical Guideline

https://www.nzx.com/announcements/447596

Now Novitas

[LoungeLizard]

Finally

Cxbladder Incorporated into AUA Clinical Guideline

https://www.nzx.com/announcements/447596

Now Novitas

Really good news for PEB and investors - may prove to be a pivotal moment for the company as CXBladder becomes part of established procedure for all clinicians.

Logically, Novitas should now withdraw the LCD and resume coverage. This decision from the AUA blows away Novitas's claim that there isn't sufficient clinical evidence to support CXBladder or that it is not clinically of benefit to patients. But of course, it has been clear for a while that Novitas aren't making their decisions based on logic.

Revenue should increase in the meantime regardless:

"Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians in the US and around the world begin to observe this updated guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria."

Finally, something for investors to cheer about!
 
 

[Greekwatchdog]

Really good news for PEB and investors - may prove to be a pivotal moment for the company as CXBladder becomes part of established procedure for all clinicians.

Logically, Novitas should now withdraw the LCD and resume coverage. This decision from the AUA blows away Novitas's claim that there isn't sufficient clinical evidence to support CXBladder or that it is not clinically of benefit to patients. But of course, it has been clear for a while that Novitas aren't making their decisions based on logic.

Revenue should increase in the meantime regardless:

"Pacific Edge anticipates an uplift in demand for Cxbladder tests as more clinicians in the US and around the world begin to observe this updated guideline and incorporate the tests into care pathways for the evaluation and management of patients presenting with microhematuria."

Finally, something for investors to cheer about!
 
 

Opening action should be interesting, then so will the Aussie reaction at opening