PEB - Pacific Edge Ltd

[bulltrap]

Report incoming...

[bulltrap]

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.)

[jonu]

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.)

"Novitas' default position is to affirm the LCD to remove coverage as status quo at the end of the review period."

How do you know that?

[850man]

"Novitas' default position is to affirm the LCD to remove coverage as status quo at the end of the review period."

How do you know that?

It's what they did this time last year.

[snigmac]

It's what they did this time last year.

Didn't they give PEB a further year of coverage? Wouldn't a further year of coverage be the default position?

[bulltrap]

"Novitas' default position is to affirm the LCD to remove coverage as status quo at the end of the review period."

How do you know that?

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:

• 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.

[snigmac]

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:

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.

[bulltrap]

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:

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.

[snigmac]

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:

It's not news exactly, but quoting the Annual Report released today:

So in the event of a reconsideration, that will trigger a further year of coverage of Medicare?

[bulltrap]

So in the event of a reconsideration, that will trigger a further year of coverage of Medicare?

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.