PEB-Pacific Edge

[LoungeLizard]

Not long now to the Novitas decision, and I don't think anyone has a clue as to which way it will go. I'm getting a bottle of champagne in to celebrate or drown my sorrows with on the 26th    

[Pierre]

Waiting..... waiting........ holding on....... holding on....

It's a bit agonising isn't it. I'm hoping for the best but I'm really expecting a negative outcome from Novitas this month.
If that's the case, it's gonna be quite a grind for PEB for a year or three, but I'm confident they will succeed eventually.
Patience, young grasshopper. Trouble is I'm an old grasshopper now!

[Magic78]

Its a little hard to read as the CMS website is not displaying correctly for me, but I think the proposed LCD now has a 'retirement date'. I assume this means it won't continue?

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39667&ver=9#lblRetirementDateSubheader

[Left Field]

Its a little hard to read as the CMS website is not displaying correctly for me, but I think the proposed LCD now has a 'retirement date'. I assume this means it won't continue?

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39667&ver=9#lblRetirementDateSubheader

Indeed it is hard to read or understand the context of your first post....I suspect you are looking at an old report as it seemingly repeats now discredited claims, eg  male sample bias ( perhaps OK because it's primarily a male issue) etc etc???

Best to wait for the official word in a more readable/reputable format.

[Pierre]

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!

[LoungeLizard]

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!

Interesting days ahead indeed!

I hold far more than is sensible but like you Pierre, I'm not convinced Novitas will come to the party. But by God, there will be a party if they do!

It really is hard to judge what is going on behind the scenes. You could argue it both ways that the absence of a decision before the deadline could either mean Novitas are holding firm with the original decision or they have been allowing PEB to strengthen their position, so they can say that "things have changed" and continue inclusion. Or maybe there will be a fudge and inclusion will be rolled over for another year, to allow for the FDA to get involved.

But in the end, no-one knows. Logically, the bio-marking technology that PEB employ is a win-win-win for patients, urologists and insurance providers and it should be a no-brainer for all providers to embrace it. But the politics of the US health industry seems to defy both industry experts and the evidence, and really casts a long shadow over investor confidence.


Oh well, not long now. I remain eternally optimistic that no matter what happens, eventually sense will prevail and PEB will have the last laugh. Just hope it's sooner, rather than later!

[winner (n)]

With the excitement of OCA and WHS today it's looking like it's going to be PEB's turn later in week with a 100% gain ...the stars are aligning

[LoungeLizard]

With the excitement of OCA and WHS today it's looking like it's going to be PEB's turn later in week with a 100% gain ...the stars are aligning

I tell you what Winner, if PEB"S coverage is re-instated we will be looking more like a 200% gain in short order, and after that who knows?
PEB were tracking around $1.50 before the Novitas decision and there was a real buzz about its growth prospects. Could it, over time, get back to those levels if they win this battle and maybe start getting other providers on board?

[LoungeLizard]

Medicare Coverage Determination Still Under Review
26/07/2024, 09:42 NZST, GENERAL
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.
 
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Wow - they've had a whole year to decide and it's still under discussion? I read this as very good news though as it looks as though Novitas are trying to find a way of moderating the initial decision. They would have said no outright otherwise. Wonder how the market  will see it? 
 

[Left Field]

No decision better than a bad decision..

Looking more positive IMHO.

( I suspect the delay is Novitas being very careful about possible legal action....however I hope this never comes to a legal dispute.)

[Magic78]

Novitas has been granted an extension https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00006150

No timeframe provided.

Also discussed on this blog https://www.discoveriesinhealthpolicy.com/

[Greekwatchdog]

Novitas has been granted an extension https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00006150

No timeframe provided.

Also discussed on this blog https://www.discoveriesinhealthpolicy.com/

Thanks for posting. I will take this as a positive development for mine.

[Pierre]

Novitas has been granted an extension https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00006150

No timeframe provided.

Also discussed on this blog https://www.discoveriesinhealthpolicy.com/

PEB and the AUA both submitted responses on the LCD to Novitas in September 2023. It's now July 2024 - Novitas must be staffed with very slow readers, or very slow thinkers.

[Left Field]

On the other channel Snigmac makes the following observation which aligns with my thoughts....

"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."

After the first flawed decision  USA authorities stepped in and told Novitas to re-do their arguably unfair process......this latest extension only adds to the previous alleged procedural unfairness.

I'm optimistic that this will work out favourably for PEB (and hope PEB doesn't have to take the litigation option.)

[850man]

While Novitas look somewhat incompetent in that this is their 2nd swing at canceling the funding of biomarker tests and even with another year to get it right, they have failed. I think this is a positive sign for PEB. Novitas could have just confirmed the LCD on Friday and ended funding but they chose to request this extension which feels to me like they may end up doing other than just confirming the LCD in the end. Let's hope this extension doesn't drag on too long and results in a favorable outcome for PEB especially following the results of the STRATA study which IMHO highly supportive of CXB as a means to reduce unnecessary cystoscopies.
Disc: holding more than feels sensible right now