Having said that, surely they were planning for this possibility. Gross negligence if they weren’t. Tomorrow’s announcement will be very interesting.
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Having said that, surely they were planning for this possibility. Gross negligence if they weren’t. Tomorrow’s announcement will be very interesting.
They definitely have the right to appeal which they will do. That will probably be the best expenditure they are going to make in the company’s history.
For the diehards, there is still hope?
Although the latest from Novitas says there never was coverage for CXB, just the creation of billing codes. This is at odds with PEB's statement to the market on 3 July 2020 the first paragraph of which follows:
"PACIFIC EDGE NOTIFIED OF POSITIVE LCD DECISION IN USA
Transformational reimbursement milestone for Pacific Edge with notification
of LCD coverage for CMS patients in the USA. The LCD coverage facilitates
reimbursement for CMS patients using Cxbladder Detect and Cxbladder Monitor."
If this is not misleading then what is?
Trading halt lifted without further announcement. Very odd!
This is what For Barr have to say for what its worth.
Proposed LCD has been finalised — not good news for PEB
The final LCD retains the reliance on evidence based guidelines for a test to be considered medically reasonable and necessary, and therefore tests to be covered. The requirement for a test to be within Category 1 or 2A of the National Comprehensive Cancer Network (NCCN) guidelines has been retained. Cxbladder is currently in Category 2B which by virtue of the reimbursement criteria rules it out of coverage. Our analysis suggests this is the only finalised LCD since 2010 to explicitly rely on NCCN guidelines as a coverage criteria. The final LCD effective date (when it appears reimbursement for PEB’s Cxbladder tests will cease) is 17 July 2023.
The key question from here is what the future coverage path within CMS looks like. A key change in the finalised LCD is that Novitas "will accept LCD reconsideration requests" as to whether tests meet CMS' reasonable and necessary criteria. The complex legalities means forming a strong view on the future coverage path right now is very difficult but US industry feedback suggests that a revision request can be lodged at any time, though the probability of a change in the near-term is “low”.
Rating and target price UNDER REVIEW until more information is provided
We have not yet had the opportunity to speak to the company and we acknowledge the coverage path from here is highly uncertain. There is a wide range of outcomes depending on the success of LCD reconsideration requests based off PEB's (and potentially others) likely objections to the finalised LCD. Until we get confirmation on the forward coverage path based off potential reconsiderations, and as new information comes to light, our rating and target price are UNDER REVIEW.
I imagine there are some very worried directors (law suits incoming) and some very excited lawyers (appeal the decision, defend the class action…). What a hot mess
Talked to the ASB Securities. NZX has lifted trading halt by.mistake. They might reverse today's transactions.
I thought EBOS had the worst announcement of the day/week/month/(maybe year?) but wow this is much worse... after being a holder way back I fully understood the whole basis for PEB's existence was to commercialize this very thing that has now been determined as 'not considered medically reasonable and necessary'... it took a bit longer than I expected to gain signoff and I cut my losses at the time accordingly, however, I was pleased to see in mid 2020 it was signed off and things looked alot brighter... for the signoff to effectively be canned just 3 years after is embarrassing at best, and at worst, looks like PEB has been deceitful and possibly fraudulent with their previous statements... will be most interesting to see how they navigate this one